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    Clinical Trial Results:
    Ensayo clínico fase II aleatorizado de vinorelbina oral y cisplatino como tratamiento de inducción y después con radioterapia concomitante frente a cisplatino y etopósido con radioterapia concomitante en cáncer de pulmón no microcítico localmente avanzado irresecable. Phase II randomized clinical trial of oral vinorelbine and cisplatin as induction treatment and then with concomitant radiotherapy versus to cisplatin and etoposide with concomitant radiotherapy in Locally advanced unresectable non-small cell lung cancer.

    Summary
    EudraCT number
    		 2010-022927-31
    Trial protocol
    		 ES  
    Global end of trial date
    16 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Sep 2020
    First version publication date
    02 Sep 2020
    Other versions
    Summary report(s)
    		 GECP_RENO_final report_summary

    Trial information

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    Trial identification
    Sponsor protocol code
    GECP10/02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grupo Español de Cáncer de Pulmón
    Sponsor organisation address
    Avenida Meridiana 358, 6ª planta, Barcelona, Spain, 08027
    Public contact
    Eva Pereira Álvarez, Grupo Español de Cáncer de Pulmón, +34 934302006, epereira@gecp.org
    Scientific contact
    Mariano Provencio, Grupo Español de Cáncer de Pulmón, +34 934302006, epereira@gecp.org
    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
    08 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    ▪ To assess the efficacy (progression-free survival (PFS)) of oral vinorelbine and cisplatin as induction treatment and then with concomitant radiotherapy. PFS is defined as the time from the time of randomization to the time of progression or death from any cause without the progression of the disease studied having occurred. In other words, patients who die without evidence of progression will be considered events on the date of death and those who have not progressed at the time of the analysis will be censored with the date of the last control.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Currently, for clinically selected unresectable stage III patients with good general condition, correct lung function, no weight loss> 5%, a normal lung volume receiving> 20Gy (V20) ≤ 35%, and with the data of a recent meta-analysis, the administration of concomitant chemotherapy and radiotherapy was consider the treatment of choice. At the moment there is no systemic treatment considered as standard nor a dose of Standard radiotherapy for these patients who are tributary to a treatment with chemotherapy and radical radiotherapy. From the literature data it appears that the cisplatin / etoposide combination is one of the most active with a median survival of 23.2 months (overall 3-year survival of 26.1%, progression-free survival around 10 months), but with some degree of toxicity (17% grade 3-4 esophagitis and 32% grade neutropenia 3-4) .
    Actual start date of recruitment
    05 Aug 2011
    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
    Spain: 140
    Worldwide total number of subjects
    140
    EEA total number of subjects
    140
    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)
    115
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 22 centers in Spain. Overall 140 patients were enrolled between August 5th, 2011 and December 16th.

    Pre-assignment
    Screening details
    		 Expected patients: n = 134 Patients included: n = 140: 69 patients in Branch A (treatment of oral Vinorelbine + Cisplatin + Radiotherapy) and 71 patients in Branch B (Etoposide + Cisplatin + Radiotherapy) Eligible patients: n = 130 Evaluable patients: n = 126

    Pre-assignment period milestones
    Number of subjects started
    		 140
    Number of subjects completed
    		 140

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 oral Vinorelbine + Cisplatin + Radiotherapy
    Arm description
    		 Eligible participants in the OVP arm received oral vinorelbine on days 1 and 8 during four 3-week cycles with cisplatin 80 mg/m2 administered intravenously (IV) on day 1 of each cycle (see Fig. 1). Oral vinorelbine dosage was 60 mg/m2 on cycle 1, 80 mg/m2 on cycle 2 and 40 mg/m2 on cycles 3 and 4. Concomitant radiotherapy consisted on 2 Gy/day administered concomitantly along cycles 3 and 4 (66 Gy). Patients received concurrent thoracic radiotherapy (TRT) using three-dimensional conformal radiotherapy technique (3DCRT). A total TRT dose of 66 Gy was administered according to the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) and the International Commission on Radiation Units & Measurements report 50 (ICRU-50)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Oral Vinorelbine: Will be administered on days 1 and 8 every 21 days for a total of 4 cycles according to the following dosage: - Cycle 1: 60 mg / m2 day 1 and 8 of the cycle - Cycle 2: 80 mg / m2 day 1 and 8 of the cycle - Cycle 3 and 4 (concomitant with radiotherapy): 40 mg / m2 day 1 and 8 of each cycle Oral vinorelbine on day 1 of the cycle will be administered 30 to 60 minutes before the infusion of cisplatin.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin: 80 mg / m2 day 1 every 21 days for 4 cycles

    Arm title
    		 Etoposide and cisplatin with radiotherapy
    Arm description
    		 Patients received etoposide 50 mg/m2 IV on days 1–5 of two 4-week cycles and cisplatin 50 mg/m2 IV on days 1 and 8 of each cycle. Concomitant radiotherapy 2 Gy/day (66 Gy) was administered on days 1–33. Patients received concurrent thoracic radiotherapy (TRT) using three-dimensional conformal radiotherapy technique (3DCRT). A total TRT dose of 66 Gy was administered according to the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) and the International Commission on Radiation Units & Measurements report 50 (ICRU-50)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received etoposide 50 mg/m2 IV on days 1–5 of two 4-week cycles

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received cisplatin 50 mg/m2 IV on days 1 and 8 of each cycle (of two 4-week cycles)

    Number of subjects in period 1
    		oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Started
    69
    71
    Completed
    64
    66
    Not completed
    5
    5
         Protocol deviation
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 140 140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 105 105
        From 65-84 years
    		 35 35
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (39 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 121 121
    Smoking status
    Units: Subjects
        Never
    		 2 2
        Former
    		 64 64
        Smoker
    		 74 74
    ECOG Status
    Units: Subjects
        ECOG 0
    		 63 63
        ECOG 1
    		 77 77
    Histopathology
    Units: Subjects
        Squamous cell /epidermoid carcinoma
    		 69 69
        Adenocarcinoma
    		 63 63
        Large cell carcinoma
    		 5 5
        Other
    		 3 3
    Initial Stage
    Units: Subjects
        IA stage
    		 1 1
        IIIA stage
    		 62 62
        IIIB stage
    		 74 74
        IV stage
    		 3 3
    Treatment compliance
    Units: Subjects
        C1
    		 8 8
        C2
    		 68 68
        C3
    		 1 1
        C4
    		 57 57
        No treated
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Etoposide + Cisplatin + Radiotherapy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT group with Etoposide + Cisplatin + Radiotherapy treatment

    Subject analysis set title
    Vinorelbine + Cisplatin + Radiotherapy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population with Vinorelbine + Cisplatin + Radiotherapy treatment

    Subject analysis sets values
    		 Etoposide + Cisplatin + Radiotherapy Vinorelbine + Cisplatin + Radiotherapy
    Number of subjects
    71
    69
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age continuous
    Units: years
        median (full range (min-max))
    61,3 (43 to 76)
    63,6 (39 to 75)
    Gender categorical
    Units: Subjects
        Female
    61
    60
        Male
    10
    9
    Smoking status
    Units: Subjects
        Never
    0
    2
        Former
    28
    36
        Smoker
    43
    31
    ECOG Status
    Units: Subjects
        ECOG 0
    30
    33
        ECOG 1
    41
    36
    Histopathology
    Units: Subjects
        Squamous cell /epidermoid carcinoma
    35
    34
        Adenocarcinoma
    33
    30
        Large cell carcinoma
    2
    3
        Other
    1
    2
    Initial Stage
    Units: Subjects
        IA stage
    1
    0
        IIIA stage
    30
    32
        IIIB stage
    39
    35
        IV stage
    1
    2
    Treatment compliance
    Units: Subjects
        C1
    5
    3
        C2
    63
    5
        C3
    0
    1
        C4
    0
    57
        No treated
    3
    3

    End points

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    End points reporting groups
    Reporting group title
    oral Vinorelbine + Cisplatin + Radiotherapy
    Reporting group description
    		 Eligible participants in the OVP arm received oral vinorelbine on days 1 and 8 during four 3-week cycles with cisplatin 80 mg/m2 administered intravenously (IV) on day 1 of each cycle (see Fig. 1). Oral vinorelbine dosage was 60 mg/m2 on cycle 1, 80 mg/m2 on cycle 2 and 40 mg/m2 on cycles 3 and 4. Concomitant radiotherapy consisted on 2 Gy/day administered concomitantly along cycles 3 and 4 (66 Gy). Patients received concurrent thoracic radiotherapy (TRT) using three-dimensional conformal radiotherapy technique (3DCRT). A total TRT dose of 66 Gy was administered according to the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) and the International Commission on Radiation Units & Measurements report 50 (ICRU-50)

    Reporting group title
    Etoposide and cisplatin with radiotherapy
    Reporting group description
    		 Patients received etoposide 50 mg/m2 IV on days 1–5 of two 4-week cycles and cisplatin 50 mg/m2 IV on days 1 and 8 of each cycle. Concomitant radiotherapy 2 Gy/day (66 Gy) was administered on days 1–33. Patients received concurrent thoracic radiotherapy (TRT) using three-dimensional conformal radiotherapy technique (3DCRT). A total TRT dose of 66 Gy was administered according to the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) and the International Commission on Radiation Units & Measurements report 50 (ICRU-50)

    Subject analysis set title
    Etoposide + Cisplatin + Radiotherapy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT group with Etoposide + Cisplatin + Radiotherapy treatment

    Subject analysis set title
    Vinorelbine + Cisplatin + Radiotherapy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population with Vinorelbine + Cisplatin + Radiotherapy treatment

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    To evaluate the efficacy (progression-free survival, PFS) of oral vinorelbine and cisplatin as induction treatment and then with concomitant radiotherapy. PFS is defined as the time from the time of randomization to the time of progression or death from any cause without the progression of the disease studied having occurred. In other words, patients who die without evidence of progression will be considered events on the date of death and those who have not progressed at the time of the analysis will be censored with the date of the last control.
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Number of subjects analysed
    69
    71
    Units: Months
        median (confidence interval 95%)
    10.8 (7.4 to 14)
    9.1 (5.5 to 12.7)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The median progression-free survival was 10.8 months (95% CI: 7.5-14) in the group VC patient group and 9.1 months (95% CI: 5.5-12.7 ) in the group EC patients with no statistically significant differences (p = 0.389). According to the main objective of the study in evaluating the efficacy of oral vinorelbine and cisplatin as induction treatment and then with concomitant radiotherapy, was considered a positive study, if the median PFS was higher 12.58 months. Therefore, the study is negative
    Comparison groups
    oral Vinorelbine + Cisplatin + Radiotherapy v Etoposide and cisplatin with radiotherapy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.389 [2]
    Method
    		 Kaplan-Meier
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.5
         upper limit
    		 14
    Notes
    [1] - According to the main objective of the study in evaluating the efficacy (survival free of progression, SLP) of oral vinorelbine and cisplatin as induction treatment and then with concomitant radiotherapy, was considered a positive study, if the median PFS was higher 12.58 months. Therefore, given that the median obtained at this time is 10.8 months, we consider the study to be negative.
    [2] - Median PFS was 10.8 months (CI95%7.7-13.8) in the OVP arm and 9.6 months in the EP arm (CI95%4.4-14.8). Comparison of median PFS between arms was statistically non-significant (p = 0.389)

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    The overall survival was analyzed as the time between the randomization of the treatment and the death from any cause. Live patients were censored on the date of the last control of follow up.
    End point type
    Secondary
    End point timeframe
    At the end of study
    End point values
    		 oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Number of subjects analysed
    69
    71
    Units: Months
        median (confidence interval 95%)
    38 (21.4 to 54.7)
    29.5 (22.3 to 36.7)
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The overall survival was analyzed as the time between the randomization of the treatment and the death from any cause.
    Comparison groups
    Etoposide and cisplatin with radiotherapy v oral Vinorelbine + Cisplatin + Radiotherapy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.65 [4]
    Method
    		 Kaplan-Meier
    Parameter type
    		 Mean difference (final values)
    Point estimate
    38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.4
         upper limit
    		 54.7
    Notes
    [3] - The median overall survival was 38 months (95% CI: 21.4-54.7) in patients in the Experimental Branch: Oral Vinoreline+ Cisplatine and 29.5 months (22.3-36.7) in patients of Comparator Branch: Etoposide and Cisplatine without finding differences statistically significant (p = 0.65) as shown by the Kaplan Meier curve.
    [4] - Comparison of the overall survival was non-significantly different between experimental and comparator branch.

    Secondary: Response duration

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    End point title
    		 Response duration
    End point description
    Describe and compare the duration of the response of the two branches, determined from the date in that the tumor response is objectified until the progression appears.
    End point type
    Secondary
    End point timeframe
    At the end of study
    End point values
    		 oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Number of subjects analysed
    69
    71
    Units: Month
        median (confidence interval 95%)
    11.9 (6.84 to 16.96)
    9.1 (2.61 to 15.59)
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Compare the duration of the response of the two branches, determined from the date in that the tumor response is objectified until the progression appears.
    Comparison groups
    oral Vinorelbine + Cisplatin + Radiotherapy v Etoposide and cisplatin with radiotherapy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.373 [6]
    Method
    		 Kaplan-Meier
    Parameter type
    		 Median difference (final values)
    Point estimate
    11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.61
         upper limit
    		 16.96
    Notes
    [5] - The duration of response was analyzed in the treatment group of Experimental Branch and in the group Comparator Branch treatment without statistically significant differences between the treatment groups (p = 0.373)
    [6] - Comparison of the duration of the response was non-significantly different.

    Secondary: Comparison of objective tumor response by treatment branch

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    End point title
    		 Comparison of objective tumor response by treatment branch
    End point description
    Describe and compare the objective response rate of the two treatment branches, by evaluating of the target lesions according to the RECIST criteria (version 1.1).
    End point type
    Secondary
    End point timeframe
    At the end of study
    End point values
    		 oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Number of subjects analysed
    63
    63
    Units: Subjects
        Objetive Response YES
    39
    41
        Objetive response NO
    24
    22
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Describe and compare the objective response rate of the two treatment branches, by evaluating of the target lesions according to the RECIST criteria (version 1.1).
    Comparison groups
    oral Vinorelbine + Cisplatin + Radiotherapy v Etoposide and cisplatin with radiotherapy
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.711
    Method
    		 Kaplan-Meier
    Confidence interval
    Notes
    [7] - The objective response by treatment branch was compared and no statistically significant differences were found (p = 0.711).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event or breakdown occurring during the course of the study.
    Adverse event reporting additional description
    The severity of AE will be determined using CTCAE version 4.0. In the OVP arm, treatment discontinuation due to death was reported in three cases (one due to disease progression, one to non-treatment-related (NTR) bronchopulmonary haemorrhage and one to cisplatin-related nephrotoxicity). In EC arm one death was due G4 necrotizing fasciitis (NTR).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    oral Vinorelbine + Cisplatin + Radiotherapy
    Reporting group description
    		 Eligible participants in the OVP arm received oral vinorelbine on days 1 and 8 during four 3-week cycles with cisplatin 80 mg/m2 administered intravenously (IV) on day 1 of each cycle (see Fig. 1). Oral vinorelbine dosage was 60 mg/m2 on cycle 1, 80 mg/m2 on cycle 2 and 40 mg/m2 on cycles 3 and 4. Concomitant radiotherapy consisted on 2 Gy/day administered concomitantly along cycles 3 and 4 (66 Gy). Patients received concurrent thoracic radiotherapy (TRT) using three-dimensional conformal radiotherapy technique (3DCRT). A total TRT dose of 66 Gy was administered according to the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) and the International Commission on Radiation Units & Measurements report 50 (ICRU-50)

    Reporting group title
    Etoposide and cisplatin with radiotherapy
    Reporting group description
    		 Patients received etoposide 50 mg/m2 IV on days 1–5 of two 4-week cycles and cisplatin 50 mg/m2 IV on days 1 and 8 of each cycle. Concomitant radiotherapy 2 Gy/day (66 Gy) was administered on days 1–33. Patients received concurrent thoracic radiotherapy (TRT) using three-dimensional conformal radiotherapy technique (3DCRT). A total TRT dose of 66 Gy was administered according to the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) and the International Commission on Radiation Units & Measurements report 50 (ICRU-50)

    Serious adverse events
    		 oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 66 (24.24%)
    18 / 68 (26.47%)
         number of deaths (all causes)
    3
    1
         number of deaths resulting from adverse events
    2
    1
    Injury, poisoning and procedural complications
    Vertebral fracture
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Vasovagal syncope
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    5 / 66 (7.58%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    5 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Mucositis
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Esophageal stricture
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomits
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhea
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Esophagitis
         subjects affected / exposed
    0 / 66 (0.00%)
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 66 (3.03%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Broncopulmonar hemorragia & necrosis
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory infection
         subjects affected / exposed
    0 / 66 (0.00%)
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrological toxicity
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Infections and infestations
    Necrotizing fasciitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 oral Vinorelbine + Cisplatin + Radiotherapy Etoposide and cisplatin with radiotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 66 (21.21%)
    43 / 68 (63.24%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    3 / 66 (4.55%)
    0 / 68 (0.00%)
         occurrences all number
    3
    0
    Seizure crisis
         subjects affected / exposed
    0 / 66 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 66 (9.09%)
    1 / 68 (1.47%)
         occurrences all number
    6
    1
    Chest pain
         subjects affected / exposed
    1 / 66 (1.52%)
    2 / 68 (2.94%)
         occurrences all number
    1
    2
    Anorexy
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Lipothymia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 66 (1.52%)
    4 / 68 (5.88%)
         occurrences all number
    1
    4
    Neutropenia
         subjects affected / exposed
    10 / 66 (15.15%)
    19 / 68 (27.94%)
         occurrences all number
    10
    19
    Hemoglobin
    Additional description: Hematologic toxicity
         subjects affected / exposed
    1 / 66 (1.52%)
    4 / 68 (5.88%)
         occurrences all number
    1
    4
    Leukocytes
    Additional description: Hematologic toxicity
         subjects affected / exposed
    5 / 66 (7.58%)
    12 / 68 (17.65%)
         occurrences all number
    5
    12
    Neutrophils
    Additional description: Hematologic toxicity
         subjects affected / exposed
    11 / 66 (16.67%)
    12 / 68 (17.65%)
         occurrences all number
    11
    12
    Platelets
    Additional description: Hematological toxicity
         subjects affected / exposed
    3 / 66 (4.55%)
    4 / 68 (5.88%)
         occurrences all number
    3
    4
    INR increase
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Lymphopenia
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 68 (2.94%)
         occurrences all number
    3
    2
    Esophagitis
         subjects affected / exposed
    1 / 66 (1.52%)
    12 / 68 (17.65%)
         occurrences all number
    1
    12
    Mucositis
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Vomits
         subjects affected / exposed
    4 / 66 (6.06%)
    1 / 68 (1.47%)
         occurrences all number
    4
    1
    Esophageal stricture
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 66 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Respiratory infection
         subjects affected / exposed
    2 / 66 (3.03%)
    3 / 68 (4.41%)
         occurrences all number
    2
    3
    Bronchospasm
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Hemoptysis
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 66 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    3 / 66 (4.55%)
    0 / 68 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Nov 2012
    Extension of the selection period that precedes registration and includes the 42-day period for completion of the valuation scans instead of 28 days. Therefore there is a period extension for the completion of the PET-CT and thoraco-abdominal CT prior to treatment period.
    26 Jun 2013
    Selection criteria are modified. It is added as new exclusion criterion: patients who have received previous surgery for the disease.

    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/31446990
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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