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    Clinical Trial Results:
    Neoadjuvant chemotherapy and extrapleural pneumonectomy of malignant pleural mesothelioma (MPM) with or without hemithoracic radiotherapy. A randomized multicenter phase II trial

    Summary
    EudraCT number
    		 2006-000445-19
    Trial protocol
    		 DE   BE  
    Global end of trial date
    18 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SAKK 17/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00334594
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Swiss Group for Clinical Cancer Research (SAKK)
    Sponsor organisation address
    Effingerstrasse 33, Bern, Switzerland, 3008
    Public contact
    Head Regulatory Affairs, Swiss Group for Clinical Cancer, +41 31389 91 91, sakkcc@sakk.ch
    Scientific contact
    Head Regulatory Affairs, Swiss Group for Clinical Cancer, +41 31389 91 91, sakkcc@sakk.ch
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the trial are to evaluate the short-term outcomes and feasibility of neoadjuvant chemotherapy and extrapleural pneumonectomy in Part 1, and long-term outcomes and feasibility of hemithoracic radiotherapy in patients with R0 and R1 resection in Part 2.
    Protection of trial subjects
    Protection of trial subjects was ensured by Safety Monitoring, i.e. assessment of adverse events, serious adverse events, adverse drug reactions, and the continous assessment of laboratory values and vital signs.
    Background therapy
    		 None.
    Evidence for comparator
    		 Not applicable. The study investigated the effect of hemithoracic radiotherapy (Arm B) versus no radiotherapy (Arm A) after treatment with pemetrexed/cisplatin and subsequent extrapleural pneumonectomy.
    Actual start date of recruitment
    07 Dec 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Switzerland: 139
    Worldwide total number of subjects
    151
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    108
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between December 2005 and November 2012, 153 patients were included into the trial at 14 centers in Switzerland (12 centers), Germany (1 center) and Belgium (1 center).

    Pre-assignment
    Screening details
    		 Eligibility criteria of a patient were checked by the investigator. Once a patient fullfils all inclusion criteria and not any of the exclusion criteria, he/she was enrolled. Of the 153 registered patients, two patients were excluded due to direct refusal after registration and missing information about chemotherapy during external treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 153 [1]
    Number of subjects completed
    		 151

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Missing information about chemotherapy: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Two patients (one patient from Switzerland and one patient from Germany) were excluded (see pre-assigment period for details).
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 Baseline
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Alimta®
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 every 21 days.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 75 mg/m2 as an infusion, over approximately 2 hours on day 1 of each 21-day cycle beginning approximately 30 minutes after the end of administration of pemetrexed.

    Number of subjects in period 1
    		Baseline
    Started
    151
    Completed
    151
    Period 2
    Period 2 title
    Chemotherapy (Pemetrexed / Cisplatin)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Chemotherapy
    Arm description
    		 3 cycles of chemotherapy prior to extrapleural pneumonectomy (and hemithoracic radiotherapy).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Alimta®
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 every 21 days.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 75 mg/m2 as an infusion, over approximately 2 hours on day 1 of each 21-day cycle beginning approximately 30 minutes after the end of administration of pemetrexed.

    Number of subjects in period 2
    		Chemotherapy
    Started
    151
    Completed
    145
    Not completed
    6
         Symptomatic deterioration
    1
         Other
    2
         Progression
    3
    Period 3
    Period 3 title
    Surgery (extrapleural pneumonectomy)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Extrapleural pneumonectomy
    Arm description
    		 Extrapleural pneumonectomy
    Arm type
    		 Surgical intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Extrapleural pneumonectomy
    Started
    145
    Completed
    125
    Not completed
    20
         Consent withdrawn by subject
    3
         Toxicity
    1
         Other
    3
         Progression
    10
         Unknown
    1
         Infiltration of other organs
    2
    Period 4
    Period 4 title
    Macroscopic resection (R0/R1)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Patients with macroscopic resection R0/R1
    Arm description
    		 Patients with chemotherapy and extrapleural pneumonectomy showing macroscopic resection R0/R1.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Patients with macroscopic resection R0/R1
    Started
    125
    Completed
    99
    Not completed
    26
         Macroscopic resection not (R0/R1)
    26
    Period 5
    Period 5 title
    Eligibility assessment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Eligibility assessment
    Arm description
    		 Patients after chemotherapy and extrapleural pneumonectomy with macroscopic resection status R0/R1.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 5
    		Eligibility assessment
    Started
    99
    Completed
    54
    Not completed
    45
         Consent withdrawn by subject
    20
         Not eligible
    10
         Death
    8
         Other
    7
    Period 6
    Period 6 title
    Hemithoracic radiotherapy
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Without RT
    Arm description
    		 No radiotherapy after 3 cycles of chemotherapy and extrapleural pneumonectomy.
    Arm type
    		 No RT

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Hemithoracic RT
    Arm description
    		 Hemithoracic radiotherapy after 3 cycles of chemotherapy and extrapleural pneumonectomy. Schedule 1: 25 x 1,8 Gy = 45 Gy to PTV1 followed by 7 x 1,8 Gy = 12, 6 Gy to PTV2 total 57,6 Gy, alternatively a schedule with 2 Gy single fraction was possible. Schedule 2: 23 x 2 Gy = 46 Gy to PTV1 followed by 5 x 2 Gy to PTV 2 total 56 Gy. Schedule 3 for intensity-modulated RT with or without integrated simultaneous boost: 26 x 1.75 Gy to PTV1 (45,5 Gy) including simultaneous internal boost to PTV2: 26 x 2.15 Gy (55,9 Gy).
    Arm type
    		 Hemithoracic RT

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 6
    		Without RT Hemithoracic RT
    Started
    27
    27
    Completed
    27
    25
    Not completed
    0
    2
         Death
    -
    1
         Symptomatic deterioration and PD
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Baseline

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 151 151
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 108 108
        From 65-84 years
    		 43 43
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 137 137
    Subject analysis sets

    Subject analysis set title
    Part B: Non-randomized patients with CT and surgery
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with chemotherapy and extrapleural pneumonectomy who were not randomized.

    Subject analysis set title
    Part B: Arm A - No radiotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized patients with chemotherapy and extrapleural pneumonectomy receiving no radiotherapy.

    Subject analysis set title
    Part B: Arm B - Hemithoracic radiotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized patients with chemotherapy and extrapleural pneumonectomy receiving hemithoracic radiotherapy.

    Subject analysis set title
    Part A: Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients of Part A (Chemotherapy and extrapleural pneumonectomy)

    Subject analysis sets values
    		 Part B: Non-randomized patients with CT and surgery Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy Part A: Full Analysis Set
    Number of subjects
    97
    27
    27
    151
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    71
    19
    18
    108
        From 65-84 years
    26
    8
    9
    43
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    10
    3
    1
    14
        Male
    87
    24
    26
    137

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Baseline
    Reporting group title
    Chemotherapy
    Reporting group description
    		 3 cycles of chemotherapy prior to extrapleural pneumonectomy (and hemithoracic radiotherapy).
    Reporting group title
    Extrapleural pneumonectomy
    Reporting group description
    		 Extrapleural pneumonectomy
    Reporting group title
    Patients with macroscopic resection R0/R1
    Reporting group description
    		 Patients with chemotherapy and extrapleural pneumonectomy showing macroscopic resection R0/R1.
    Reporting group title
    Eligibility assessment
    Reporting group description
    		 Patients after chemotherapy and extrapleural pneumonectomy with macroscopic resection status R0/R1.
    Reporting group title
    Without RT
    Reporting group description
    		 No radiotherapy after 3 cycles of chemotherapy and extrapleural pneumonectomy.

    Reporting group title
    Hemithoracic RT
    Reporting group description
    		 Hemithoracic radiotherapy after 3 cycles of chemotherapy and extrapleural pneumonectomy. Schedule 1: 25 x 1,8 Gy = 45 Gy to PTV1 followed by 7 x 1,8 Gy = 12, 6 Gy to PTV2 total 57,6 Gy, alternatively a schedule with 2 Gy single fraction was possible. Schedule 2: 23 x 2 Gy = 46 Gy to PTV1 followed by 5 x 2 Gy to PTV 2 total 56 Gy. Schedule 3 for intensity-modulated RT with or without integrated simultaneous boost: 26 x 1.75 Gy to PTV1 (45,5 Gy) including simultaneous internal boost to PTV2: 26 x 2.15 Gy (55,9 Gy).

    Subject analysis set title
    Part B: Non-randomized patients with CT and surgery
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with chemotherapy and extrapleural pneumonectomy who were not randomized.

    Subject analysis set title
    Part B: Arm A - No radiotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized patients with chemotherapy and extrapleural pneumonectomy receiving no radiotherapy.

    Subject analysis set title
    Part B: Arm B - Hemithoracic radiotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized patients with chemotherapy and extrapleural pneumonectomy receiving hemithoracic radiotherapy.

    Subject analysis set title
    Part A: Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients of Part A (Chemotherapy and extrapleural pneumonectomy)

    Primary: PE | Part 1: Complete macroscopic resection

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    End point title
    		 PE | Part 1: Complete macroscopic resection [1]
    End point description
    Complete resection defined as macroscopic resection R0/R1. 125 out of 151 patients underwent surgery.
    End point type
    Primary
    End point timeframe
    After extrapleural pneumonectomy.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Part A of this study contained only one arm. Thus no comparative statistical analyses are available for the primary endpoint of this part.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: Patients (%)
    number (confidence interval 95%)
        All
    63.6 (55.9 to 71.3)
        Subgroup - operated patients
    85 (78.4 to 91.6)
    No statistical analyses for this end point

    Primary: PE | Part 2: Loco-regional relapse-free survival

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    End point title
    		 PE | Part 2: Loco-regional relapse-free survival [2]
    End point description
    Loco-regional relapse free survival was calculated for all patients with R0 or R1 resection from surgery until the first occurrence of loco-regional relapse (relapse in the ipsilateral hemithorax) according to the definitions below or until death. Local relapse: Relapses in the region of the former pleura, the pleura replacement, the thoracic wall and the mediastinum. Regional relapse: Lymph node metastases (=N2) in the mediastinum, ipsilateral. Out of 27 patients per arm, 26 patients showed an LR RFS event (Arm A: Relapse/progression = 24; Death = 2 || Arm B: Relapse/progression = 20; Death = 6).
    End point type
    Primary
    End point timeframe
    From surgery until first occurrence of loco-regional relapse or death.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparative statistical analyses have been performed for this endpoint.
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    27
    27
    Units: Relapse free survival (months)
        median (confidence interval 95%)
    7.6 (4.5 to 10.7)
    9.4 (6.5 to 11.9)
    No statistical analyses for this end point

    Primary: PE | Part 2: Loco-regional relapse-free survival rate at year 1 to 3

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    End point title
    		 PE | Part 2: Loco-regional relapse-free survival rate at year 1 to 3 [3]
    End point description
    Percentage of patients with loco-regional relapse-free survival at year one, two and three.
    End point type
    Primary
    End point timeframe
    At year one, two and three.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparative statistical analyses have been performed for this endpoint.
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    27
    27
    Units: Patients (%)
    number (confidence interval 95%)
        1-year LR RFS
    29.2 (13.6 to 46.7)
    29.6 (14.4 to 47.0)
        2-year LR RFS
    8.3 (1.5 to 23.1)
    18.5 (6.7 to 34.8)
        3-year LR RFS
    4.2 (0.3 to 17.5)
    7.4 (1.3 to 21.0)
    No statistical analyses for this end point

    Secondary: SE | Part 1: Response to chemotherapy

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    End point title
    		 SE | Part 1: Response to chemotherapy
    End point description
    Response to chemotherapy (objective response rate, ORR) defined as complete response (CR) or partial response (PR).
    End point type
    Secondary
    End point timeframe
    From start of chemotherapy until end of chemotherapy.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: Patients (%)
        number (confidence interval 95%)
    34.4 (26.8 to 42.0)
    No statistical analyses for this end point

    Secondary: SE | Part 1: Operability

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    End point title
    		 SE | Part 1: Operability
    End point description
    Proportion of patients remaining operable after completing chemotherapy. This was a decision taken on clinical grounds by the thoracic surgeon. In cases where the patient had become inoperable, the reason was recorded.
    End point type
    Secondary
    End point timeframe
    At time point of surgery.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: Patients (%)
        number (confidence interval 95%)
    84.8 (79.0 to 90.5)
    No statistical analyses for this end point

    Secondary: SE | Part 1: Randomization rate

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    End point title
    		 SE | Part 1: Randomization rate
    End point description
    Patients eligible for randomization. Reasons for non-randomization included macroscopic incomplete resection, patients’ refusal or patient inability to be subjected to RT within 10 weeks after surgery.
    End point type
    Secondary
    End point timeframe
    At time point of randomization.
    End point values
    		 Eligibility assessment Part A: Full Analysis Set
    Number of subjects analysed
    99
    151
    Units: Randomizable patients (%)
        number (confidence interval 95%)
    54.6 (44.7 to 64.4)
    35.8 (28.1 to 43.4)
    No statistical analyses for this end point

    Secondary: SE | Part 1: Relapse/progression free survival

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    End point title
    		 SE | Part 1: Relapse/progression free survival
    End point description
    From the 151 patients, 145 showed events (relapse progression = 119; death = 26) and the remaining 6 patients were censored.
    End point type
    Secondary
    End point timeframe
    From registration until progression/relapse (loco-regional or distant) or death for all registered patients.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: PFS (months)
        median (confidence interval 95%)
    8.4 (7.1 to 10.7)
    No statistical analyses for this end point

    Secondary: SE | Part 1: Relapse/progression free survival rates at year 1 to 5

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    End point title
    		 SE | Part 1: Relapse/progression free survival rates at year 1 to 5
    End point description
    Percentage of patients with PFS at year one to year five.
    End point type
    Secondary
    End point timeframe
    At year one to year five.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: Patients (%)
    number (confidence interval 95%)
        1-year PFS
    35.6 (28.0 to 43.3)
        2-year PFS
    13.1 (8.2 to 19.1)
        3-year PFS
    8.9 (5.0 to 14.2)
        4-year PFS
    4.1 (1.7 to 8.3)
        5-year PFS
    2.1 (0.6 to 5.5)
    No statistical analyses for this end point

    Secondary: SE | Part 2: Feasibility of radiotherapy

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    End point title
    		 SE | Part 2: Feasibility of radiotherapy
    End point description
    Proportion of patients receiving at least 90% of planned RT dose. Out of the 27 patients receiving radiotherapy, six (22.2%) patients received RT schedule 1, five (18.5%) patients received RT schedule 2, twelve (44.4%) patients received RT schedule 3 and four (14.8%) patients received an other RT schedule.
    End point type
    Secondary
    End point timeframe
    At time-point of radiotherapy.
    End point values
    		 Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    23 [4]
    Units: Patients (%)
        number (confidence interval 95%)
    70.4 (49.8 to 86.3)
    Notes
    [4] - Four patients received „other“ schedule , so its feasibility could not be evaluated.
    No statistical analyses for this end point

    Secondary: SE | Part 2: Relapse-free survival (for randomized patients)

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    End point title
    		 SE | Part 2: Relapse-free survival (for randomized patients)
    End point description
    RFS calculated from registration until progression/ relapse (loco-regional or distant) or death for all randomized patients. 26 Events per arm were observed (Arm A: Relapse/progression = 24; Death = 2; Arm A: Relapse/progression = 20; Death = 6), one patient in each arm was censored.
    End point type
    Secondary
    End point timeframe
    From registration until progression/ relapse (loco-regional or distant) or death.
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    27
    27
    Units: RFS (months)
        median (confidence interval 95%)
    5.7 (3.5 to 8.8)
    7.6 (5.2 to 10.7)
    No statistical analyses for this end point

    Secondary: SE | Part 2: Relapse-free survival rate at year 1 to 3 (for randomized patients)

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    End point title
    		 SE | Part 2: Relapse-free survival rate at year 1 to 3 (for randomized patients)
    End point description
    Percentage of randomized patients with RFS at year one to year three.
    End point type
    Secondary
    End point timeframe
    At year one, two and three.
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    27
    27
    Units: Patients (%)
    number (confidence interval 95%)
        1-year RFS (randomized patients)
    25.0 (10.6 to 42.5)
    29.6 (14.1 to 47.0)
        2-year RFS (randomized patients)
    4.2 (0.3 to 17.5)
    18.5 (6.7 to 34.8)
        3-year RFS (randomized patients)
    4.2 (0.3 to 17.5)
    7.4 (1.3 to 21.0)
    No statistical analyses for this end point

    Secondary: SE | Part 2: Psychological distress level (quality of life)

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    End point title
    		 SE | Part 2: Psychological distress level (quality of life)
    End point description
    The Rotterdam Symptom Checklist (RSCL) was used to measure symptom-related physical and psychological distress covering four domains: (1) Psychological Distress Level (PDL), (2) Physical Symptom Distress Level (PSDL), (3) Activity Level (AL), (4) Overall Evaluation of Life (OV). The scores of the items for the physical symptom distress and psychological distress scales were reversed so that lower scores refer to a worse condition and higher scores to a better condition. All scores were standardized according to the manual of RSCL to a % percentage ranging from 0% to 100%. Then, the change scores of each RSCL domain from baseline was calculated for each patient and for each time point. Positive changes indicate that the condition became better compared to baseline. Mean changes of 8 points or more in these indicators are considered as clinically relevant.
    End point type
    Secondary
    End point timeframe
    At week 4, 8, 14, 20
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    20 [5]
    21 [6]
    Units: Score
    number (confidence interval 95%)
        PDL (4w)
    9.5 (0.0 to 19.1)
    0.0 (-4.8 to 14.3)
        PDL (8w)
    4.8 (0.0 to 14.3)
    0.0 (-9.5 to 19.1)
        PDL (14w)
    9.5 (0.0 to 14.3)
    4.8 (0.0 to 14.3)
        PDL (20w)
    14.3 (-4.8 to 19.1)
    0.0 (-4.8 to 19.1)
        PSDL (4w)
    3.6 (-1.5 to 7.8)
    0.0 (-11.1 to 1.5)
        PSDL (8w)
    4.3 (0.0 to 10.2)
    -1.4 (-7.3 to 4.4)
        PSDL (14w)
    4.3 (-10.2 to 11.6)
    4.3 (-3.0 to 8.7)
        PSDL (20w)
    5.8 (0.0 to 15.9)
    4.3 (0.0 to 13.0)
        AL (4w)
    8.3 (0.0 to 12.5)
    -6.2 (-20.8 to 12.5)
        AL (8w)
    8.3 (-4.2 to 25.0)
    0.0 (-8.3 to 33.3)
        AL (14w)
    4.2 (-7.1 to 16.7)
    0.0 (0.0 to 20.0)
        AL (20w)
    12.5 (-4.2 to 29.2)
    4.2 (0.0 to 20.8)
        OV (4w)
    0.0 (0.0 to 16.7)
    0.0 (-16.7 to 0.0)
        OV (8w)
    0.0 (0.0 to 16.7)
    0.0 (-33.3 to 16.7)
        OV (14w)
    0.0 (-16.7 to 16.7)
    0.0 (0.0 to 16.7)
        OV (20w)
    16.7 (0.0 to 33.3)
    0.0 (0.0 to 33.3)
    Attachments
    		 SAKK17/04_QoL
    Notes
    [5] - PDL/PSDL/AL: n(4w)=18; n(8w)=17; n(14w)=20; n(20w)=13 | OV: n(4w)=18; n(8w)=17; n(14w)=19; n(20w)=12
    [6] - PDL/PSDL/OV: n(4w)=21; n(8w)=15; n(14w)=17; n(20w)=13 | AL: n(4w)=20; n(8w)=14; n(14w)=16; n(20w)=13
    No statistical analyses for this end point

    Secondary: SE | Part 1: Overall survival

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    End point title
    		 SE | Part 1: Overall survival
    End point description
    Overall survival (OS) was calculated from registration until death for all registered patients. In total, 135 deaths were observed (Tumor: [87.4%]; Toxicity: [3.0%]; Other: [6.7%]; Unknown: [3.0%]).
    End point type
    Secondary
    End point timeframe
    From registration until death.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: OS (months)
        median (confidence interval 95%)
    14.9 (11.9 to 18.6)
    No statistical analyses for this end point

    Secondary: SE | Part 1: Overall survival rate at year 1 to 5

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    End point title
    		 SE | Part 1: Overall survival rate at year 1 to 5
    End point description
    OS rate for all registered patients.
    End point type
    Secondary
    End point timeframe
    At year one, two, three, four and five.
    End point values
    		 Part A: Full Analysis Set
    Number of subjects analysed
    151
    Units: Patients (%)
    number (confidence interval 95%)
        1-year OS
    57.7 (49.4 to 65.2)
        2-year OS
    30.6 (23.4 to 38.2)
        3-year OS
    20.2 (14.1 to 27.0)
        4-year OS
    11.8 (7.2 to 17.7)
        5-year OS
    9.1 (5.0 to 14.4)
    No statistical analyses for this end point

    Secondary: SE | Part 2: Overall survival

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    End point title
    		 SE | Part 2: Overall survival
    End point description
    Overall survival (OS) was calculated from randomization until death for all randomized patients. In total, 51 events were observed, 26 events in Arm A (Tumor: [88.5%]; Other: [11.5%]) and 25 events in Arm B (Tumor: [88.0%]; Other: [8.0%]; Unknown: [4.0%]).
    End point type
    Secondary
    End point timeframe
    From randomization until death.
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    27
    27
    Units: OS (months)
        median (confidence interval 95%)
    16.9 (10.7 to 22.2)
    14.9 (7.0 to 17.7)
    No statistical analyses for this end point

    Secondary: SE | Part 2: Overall survival rate at year 1 to 3

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    End point title
    		 SE | Part 2: Overall survival rate at year 1 to 3
    End point description
    OS rate for all randomized patients.
    End point type
    Secondary
    End point timeframe
    At year one, two and three.
    End point values
    		 Part B: Arm A - No radiotherapy Part B: Arm B - Hemithoracic radiotherapy
    Number of subjects analysed
    27
    27
    Units: Patients (%)
    number (confidence interval 95%)
        1-year OS
    63.0 (42.1 to 78.1)
    51.8 (31.9 to 68.5)
        2-year OS
    27.9 (12.5 to 45.6)
    25.9 (11.4 to 43.1)
        3-year OS
    12.0 (3.0 to 27.5)
    11.1 (2.8 to 25.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From registration until end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    SAF - Non-randomized patients
    Reporting group description
    		 Adverse events for all non-randomized patients.

    Reporting group title
    SAF - Arm A
    Reporting group description
    		 Adverse events for all patients allocated to Arm A.

    Reporting group title
    SAF - Arm B
    Reporting group description
    		 Adverse events for all patients allocated to Arm B.

    Serious adverse events
    		 SAF - Non-randomized patients SAF - Arm A SAF - Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 97 (31.96%)
    5 / 27 (18.52%)
    15 / 27 (55.56%)
         number of deaths (all causes)
    84
    26
    25
         number of deaths resulting from adverse events
    8
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
    Additional description: Recurrent pleural effusion related to malignant pleural mesothelioma (not regarded as progression)
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
    Additional description: Hemorrhage Grade 4 with surgery
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
    Additional description: Hemorrhagic shock due to hemothorax right after re-thoracotomy
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
    Additional description: Acute ischemia of both legs due to arterial occlusive disease. Phimosis.
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hernia repair
    Additional description: Surgery for herniation, right heart failure.
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Haematoma evacuation
    Additional description: Postoperative hemothorax, re-surgery for hemostasis and drainage
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial repair
    Additional description: Heart luxation post extrapleural pneumonectomy, diaphragm- and pericardium reconstruction
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertension
    Additional description: Pulmonary hypertension in context of extrapleural pneumonectomy and hypoxia Grade 4
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Haemothorax
    Additional description: Hematothorax and atrial fibrillation
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary air leakage
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopleural fistula
    Additional description: Broncho-pleural fistula requiring re-thoracotomy
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chylothorax
    Additional description: Chylothorax Grade 3 requiring re-thoracotomy
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Non-random.: Respiratory failure Grade 4 due to progressive post-surgical pulmonary edema | Arm B: Respiratory insufficiency (hypoxia Grade 4), atrial fibrillation (supraventricular arrhythmia Grade 3)
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: Non-random. - One Patient: Pulmonary embolism, ischemic cerebrovascular insult with hemiplegia right.
         subjects affected / exposed
    2 / 97 (2.06%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Seroma
    Additional description: Mediastinal shift and wound seroma post extrapleural pneumonectomy
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiation pneumonitis
    Additional description: Radiation pneumonitis with respiratory decompensation
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
    Additional description: Subacute myocardial infarction, subtotale arterial occlusive disease
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute right ventricular failure
    Additional description: Arrhythmia with hyperacute right ventricular heart failure
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardio-vascular arrest (ventricular arrhythmia Grade 4)
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
    Additional description: Myocardial infarction, cerebrovascular infarction
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    3 / 27 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophagitis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    Additional description: Two patients (non-random.): Nausea and vomiting
         subjects affected / exposed
    2 / 97 (2.06%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pylorospasm
    Additional description: Pylorospasm Grade 3 requiring pyloroplasty
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Vomiting Grade 3, diarrhea Grade 3 and hypokalemia Grade 3.
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia
    Additional description: Diaphragmatic herniation (post pneumonectomy) requiring re-sugery
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal haemorrhage
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infectious pleural effusion
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
    Additional description: Non-random.: [1] Post-pleuropneumonectomy empyema (PPPE) with Bronchial stump insufficiency (BSI); [2] Severe PPPE; [3] BSI and empyema, post-OP multiorgan fail.; [4] Fever due to suspected post-OP Empyema | Arm A: [1] Bronchopleural fistula and PPPE
         subjects affected / exposed
    4 / 97 (4.12%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Non-random. - One patient: Pneumonia left and renal insufficiency
         subjects affected / exposed
    3 / 97 (3.09%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Sepsis
    Additional description: Sepsis with multiorgan failure
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: One patient (Arm B): Dehydration Grade 3, dysphagia Grade 3, anorexia Grade 3, nausea Grade 2, vomiting Grade 2 during radiotherapy; one patient (non-random.): Polyuria, dehydration
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SAF - Non-randomized patients SAF - Arm A SAF - Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    91 / 97 (93.81%)
    27 / 27 (100.00%)
    27 / 27 (100.00%)
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    8 / 97 (8.25%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
         occurrences all number
    8
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    46 / 97 (47.42%)
    12 / 27 (44.44%)
    15 / 27 (55.56%)
         occurrences all number
    56
    14
    29
    Pyrexia
         subjects affected / exposed
    8 / 97 (8.25%)
    2 / 27 (7.41%)
    1 / 27 (3.70%)
         occurrences all number
    8
    2
    1
    Mucosal inflammation
         subjects affected / exposed
    5 / 97 (5.15%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    5
    0
    2
    Chest pain
         subjects affected / exposed
    43 / 97 (44.33%)
    9 / 27 (33.33%)
    13 / 27 (48.15%)
         occurrences all number
    51
    12
    18
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    27 / 97 (27.84%)
    8 / 27 (29.63%)
    9 / 27 (33.33%)
         occurrences all number
    34
    9
    12
    Dyspnoea
         subjects affected / exposed
    41 / 97 (42.27%)
    10 / 27 (37.04%)
    19 / 27 (70.37%)
         occurrences all number
    51
    11
    37
    Dysphonia
         subjects affected / exposed
    8 / 97 (8.25%)
    1 / 27 (3.70%)
    1 / 27 (3.70%)
         occurrences all number
    10
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    9 / 97 (9.28%)
    2 / 27 (7.41%)
    3 / 27 (11.11%)
         occurrences all number
    9
    2
    3
    Mood altered
         subjects affected / exposed
    5 / 97 (5.15%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    5
    0
    1
    Investigations
    Neutrophil count
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 27 (3.70%)
    3 / 27 (11.11%)
         occurrences all number
    0
    1
    3
    Weight increased
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 27 (7.41%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    1
    Weight decreased
         subjects affected / exposed
    12 / 97 (12.37%)
    2 / 27 (7.41%)
    7 / 27 (25.93%)
         occurrences all number
    13
    2
    10
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    7 / 27 (25.93%)
         occurrences all number
    1
    0
    8
    Nervous system disorders
    Taste disorder
         subjects affected / exposed
    4 / 97 (4.12%)
    5 / 27 (18.52%)
    2 / 27 (7.41%)
         occurrences all number
    4
    5
    2
    Dizziness
         subjects affected / exposed
    5 / 97 (5.15%)
    2 / 27 (7.41%)
    4 / 27 (14.81%)
         occurrences all number
    5
    2
    5
    Neuropathy peripheral
         subjects affected / exposed
    8 / 97 (8.25%)
    2 / 27 (7.41%)
    2 / 27 (7.41%)
         occurrences all number
    8
    2
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 97 (1.03%)
    1 / 27 (3.70%)
    5 / 27 (18.52%)
         occurrences all number
    1
    1
    7
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 27 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    1
    0
    3
    Ear and labyrinth disorders
    Auditory disorder
         subjects affected / exposed
    11 / 97 (11.34%)
    1 / 27 (3.70%)
    6 / 27 (22.22%)
         occurrences all number
    12
    1
    9
    Tinnitus
         subjects affected / exposed
    25 / 97 (25.77%)
    4 / 27 (14.81%)
    6 / 27 (22.22%)
         occurrences all number
    26
    4
    6
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    34 / 97 (35.05%)
    6 / 27 (22.22%)
    6 / 27 (22.22%)
         occurrences all number
    39
    6
    8
    Diarrhoea
         subjects affected / exposed
    11 / 97 (11.34%)
    2 / 27 (7.41%)
    8 / 27 (29.63%)
         occurrences all number
    12
    2
    10
    Dysphagia
         subjects affected / exposed
    1 / 97 (1.03%)
    1 / 27 (3.70%)
    4 / 27 (14.81%)
         occurrences all number
    1
    1
    4
    Oesophagitis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    8 / 27 (29.63%)
         occurrences all number
    0
    0
    11
    Dyspepsia
         subjects affected / exposed
    3 / 97 (3.09%)
    2 / 27 (7.41%)
    1 / 27 (3.70%)
         occurrences all number
    3
    2
    1
    Nausea
         subjects affected / exposed
    60 / 97 (61.86%)
    16 / 27 (59.26%)
    21 / 27 (77.78%)
         occurrences all number
    72
    17
    39
    Vomiting
         subjects affected / exposed
    20 / 97 (20.62%)
    3 / 27 (11.11%)
    11 / 27 (40.74%)
         occurrences all number
    24
    3
    16
    Abdominal pain
         subjects affected / exposed
    5 / 97 (5.15%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    5
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    6 / 97 (6.19%)
    1 / 27 (3.70%)
    3 / 27 (11.11%)
         occurrences all number
    6
    1
    3
    Erythema
         subjects affected / exposed
    2 / 97 (2.06%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    2
    0
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 97 (21.65%)
    6 / 27 (22.22%)
    12 / 27 (44.44%)
         occurrences all number
    22
    6
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2007
    Amendment 1: Changes in the ordering of Pemetrexed by Eli Lilly (Suisse) for the Swiss centers participating only, as it was paid by the health insurances since 1st February 2007. Also some administrative items were changed and exclusion criteria were completed.
    06 Jun 2008
    Amendment 2: Changes in the feasibility control in order to check the feasibility of randomization alone. Also some administrative changes were made regarding trial medication and SAE reporting, so as to allow more foreign centers to participate in this trial. There was a new release of particular CRFs.
    11 Feb 2010
    Amendment 3: Recently published clinical data from the University Hospital Zurich and other centers that mostly reflect single institution experiences suggested improved dose constraints for the contralateral lung when postoperative hemithoracic. Second, according to the last SAKK safety report (Sept. 2008) one patient treated with IMRT at the University Hospital Zurich suffered from grade 4 pneumonitis. Replanning of the physics plan in this patient suggested that there was room for improvement if the novel lung constraints were used for treatment planning. Also, the shipment for blocks on dry ice was adapted according to guidelines from Swiss Post.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26538423
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