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    Clinical Trial Results:
    Randomized, controlled trial of Platinum-Cetuximab combined either with Docetaxel (TPEx) or with 5FU (Extreme) in patients with recurrent/metastatic squamous cell cancer of the head and neck

    Summary
    EudraCT number
    		 2014-000048-14
    Trial protocol
    		 ES   DE  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2023
    First version publication date
    19 Nov 2023
    Other versions
    Summary report(s)
    		 summary of report

    Trial information

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    Trial identification
    Sponsor protocol code
    TPEXTREME
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02268695
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 TPExtreme: GORTEC 2014-01
    Sponsors
    Sponsor organisation name
    GORTEC
    Sponsor organisation address
    4 Bis Rue Emile Zola, TOURS, France, 37000
    Public contact
    Laura Sinigaglia, GORTEC, laura.sinigaglia@gortec.fr
    Scientific contact
    Pr Joël GUIGAY, GORTEC, joel.guigay@gortec.fr
    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
    20 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    to compare in terms of overall survival the TPEx and EXTREME regimens as first line treatment of patients with recurrent / metastatic HN SCC
    Protection of trial subjects
    Follow-up of patients according to the protocol calendar, adaptation of treatment or discontinuation of treatment according to toxicities
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Oct 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 68
    Country: Number of subjects enrolled
    France: 409
    Country: Number of subjects enrolled
    Germany: 64
    Worldwide total number of subjects
    541
    EEA total number of subjects
    541
    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)
    438
    From 65 to 84 years
    103
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study is presented to patients during a standard visit by theinvestigator. If the patient agrees to participate and meets the eligibility criteria, then they can be included in the trial.

    Pre-assignment
    Screening details
    		 - Histologically confirmed diagnosis squamous cell carcinoma of head and neck: oral cavity, oropharynx, hypopharynx, larynx (histological confirmation is mandatory at least for initial diagnosis). - Recurrence and/or metastatic disease not suitable for local therapy. - At least one measurable lesion (RECIST) by CT or MRI.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard treatment (EXTREME)
    Arm description
    		 6 cycles every 3 weeks - Cisplatin: 100 mg/m² iv on Day1 - 5FU: 4000 mg/m² total dose starting on day 1 and during 96h in continuous infusion - Cetuximab: 400 mg/m² iv on Day1 (loading dose), then 250 mg/m² iv weekly. - If Cisplatin is not tolerated and/or when the total cumulative dose of cisplatin (including prior administration) reaches 600 mg/m², cisplatin has to be replaced by carboplatin, AUC 5, except in the case of bleeding tumor.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m² iv on Day1

    Investigational medicinal product name
    5-Fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Concentrate for solution for injection
    Routes of administration
    Infusion , Injection
    Dosage and administration details
    4000 mg/m² total dose starting on day 1 and during 96h in continuous infusion

    Investigational medicinal product name
    cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m² iv on Day1 (loading dose), then 250 mg/m² iv weekly.

    Arm title
    		 Experimental treatment (TPEx)
    Arm description
    		 - 4 cycles every 3 weeks - Cisplatin: 75 mg/m² iv on Day1 - Docetaxel: 75 mg/m² iv on Day1 - Cetuximab: 400 mg/m² iv on Day1 (loading dose) then 250 mg/m² iv weekly. - If cisplatin is not tolerated, cisplatin has to be replaced by carboplatin, AUC 5, except in the case of bleeding tumor. Primary prophylactic administration of GCSF was administered systematically after each cycle of chemotherapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75mg/m² iv on Day1

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m² iv on Day1

    Investigational medicinal product name
    cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m² iv on Day1 (loading dose) then 250 mg/m² iv weekly.

    Number of subjects in period 1
    		Standard treatment (EXTREME) Experimental treatment (TPEx)
    Started
    270
    271
    Completed
    118
    191
    Not completed
    152
    80
         Adverse event, serious fatal
    21
    10
         Physician decision
    4
    2
         Consent withdrawn by subject
    17
    6
         Adverse event, non-fatal
    36
    20
         no treatment received
    6
    8
         other toxicity
    -
    17
         Lost to follow-up
    2
    1
         missing reason
    -
    1
         Tumor progression
    34
    13
         other reason
    32
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard treatment (EXTREME)
    Reporting group description
    		 6 cycles every 3 weeks - Cisplatin: 100 mg/m² iv on Day1 - 5FU: 4000 mg/m² total dose starting on day 1 and during 96h in continuous infusion - Cetuximab: 400 mg/m² iv on Day1 (loading dose), then 250 mg/m² iv weekly. - If Cisplatin is not tolerated and/or when the total cumulative dose of cisplatin (including prior administration) reaches 600 mg/m², cisplatin has to be replaced by carboplatin, AUC 5, except in the case of bleeding tumor.

    Reporting group title
    Experimental treatment (TPEx)
    Reporting group description
    		 - 4 cycles every 3 weeks - Cisplatin: 75 mg/m² iv on Day1 - Docetaxel: 75 mg/m² iv on Day1 - Cetuximab: 400 mg/m² iv on Day1 (loading dose) then 250 mg/m² iv weekly. - If cisplatin is not tolerated, cisplatin has to be replaced by carboplatin, AUC 5, except in the case of bleeding tumor. Primary prophylactic administration of GCSF was administered systematically after each cycle of chemotherapy.

    Reporting group values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx) Total
    Number of subjects
    		 270 271 541
    Age categorical
    Age ≥ 18 years and < 71 years.
    Units: Subjects
        Adults (18-64 years)
    		 223 215 438
        From 65-71 years
    		 47 56 103
    Age continuous
    Units: years
        median (full range (min-max))
    		 60 (23 to 71) 60 (38 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 39 31 70
        Male
    		 231 240 471

    End points

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    End points reporting groups
    Reporting group title
    Standard treatment (EXTREME)
    Reporting group description
    		 6 cycles every 3 weeks - Cisplatin: 100 mg/m² iv on Day1 - 5FU: 4000 mg/m² total dose starting on day 1 and during 96h in continuous infusion - Cetuximab: 400 mg/m² iv on Day1 (loading dose), then 250 mg/m² iv weekly. - If Cisplatin is not tolerated and/or when the total cumulative dose of cisplatin (including prior administration) reaches 600 mg/m², cisplatin has to be replaced by carboplatin, AUC 5, except in the case of bleeding tumor.

    Reporting group title
    Experimental treatment (TPEx)
    Reporting group description
    		 - 4 cycles every 3 weeks - Cisplatin: 75 mg/m² iv on Day1 - Docetaxel: 75 mg/m² iv on Day1 - Cetuximab: 400 mg/m² iv on Day1 (loading dose) then 250 mg/m² iv weekly. - If cisplatin is not tolerated, cisplatin has to be replaced by carboplatin, AUC 5, except in the case of bleeding tumor. Primary prophylactic administration of GCSF was administered systematically after each cycle of chemotherapy.

    Primary: Overall survival

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    End point title
    		 Overall survival [1]
    End point description
    Overall survival (OS): defined as the time to death from any cause measured from randomization. Patients with disease progression may be treated with off protocol therapy but will be followed for overall survival evaluation.
    End point type
    Primary
    End point timeframe
    At the end of study
    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: The analysis of efficacy endpoints was done in the Intent to Treat (ITT) population. The toxicity analysis was done in the population of patients who received at least one administration of chemotherapy or cetuximab.
    End point values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx)
    Number of subjects analysed
    243
    234
    Units: Survival rate
        number (confidence interval 95%)
    13.4 (12.2 to 15.8)
    14.5 (12.5 to 15.8)
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response rate (complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and assessed by central imaging review) at 12 weeks, by local assessment and by centralized review.
    End point type
    Secondary
    End point timeframe
    At the end of trial
    End point values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx)
    Number of subjects analysed
    270
    269
    Units: Survival rate
        number (confidence interval 95%)
    5.9 (5.3 to 6.3)
    5.1 (4.6 to 6.6)
    No statistical analyses for this end point

    Secondary: Best overall tumor response rate

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    End point title
    		 Best overall tumor response rate
    End point description
    Best overall tumor response rate (RECIST v.1.1 criteria) during treatment by local assessment
    End point type
    Secondary
    End point timeframe
    During the treatment
    End point values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx)
    Number of subjects analysed
    270
    269
    Units: Survival rate
        number (confidence interval 95%)
    5.9 (5.3 to 6.3)
    5.1 (4.6 to 6.6)
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS)
    End point description
    Progression free survival (PFS): minimum time from randomization to progression as defined by RECIST v. 1.1 criteria or to death from any cause. Patients who did not have any of these events were censored at the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    from randomization until progression
    End point values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx)
    Number of subjects analysed
    255
    248
    Units: Survival rate
        number (confidence interval 95%)
    6.2 (5.8 to 6.7)
    6.0 (5.7 to 6.4)
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

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    End point title
    		 Time to Progression (TTP)
    End point description
    Time to Progression (TTP): minimum time from randomization to progression as defined by RECIST v.1.1 criteria. In case of death from other cause than cancer and no prior progression, the patient was censored at the time of death. In case of death related to cancer without an accurate date of progression before death, the patient was considered in progression at the time of death. In the event of no progression and no death, the patient was censored at the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    from randomization to progression
    End point values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx)
    Number of subjects analysed
    235
    232
    Units: Survival rate
        median (confidence interval 95%)
    6.6 (6.1 to 7.3)
    6.2 (5.9 to 7.4)
    No statistical analyses for this end point

    Secondary: Health related quality of life (QoL)

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    End point title
    		 Health related quality of life (QoL)
    End point description
    Health related quality of life (QoL) assessed by EORTC QLQ-C30. The primary endpoint of the QoL study was the global health status/quality of-life scale of the QLQ-C30 questionnaire.
    End point type
    Secondary
    End point timeframe
    During the treatment
    End point values
    		 Standard treatment (EXTREME) Experimental treatment (TPEx)
    Number of subjects analysed
    270
    269
    Units: Survival rate
        arithmetic mean (confidence interval 95%)
    57 (55 to 60)
    60 (57 to 63)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were described during chemotherapy and during maintenance
    Adverse event reporting additional description
    Any SAE which occurs or comes to the attention of the investigator at any time during the study, since study treatment is started and within 30 days after the last administration of study drugs independent of the circumstances or suspected cause, must be reported immediately, within 24 hours of knowledge (at latest on the next working day).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    EXTREME
    Reporting group description
    		 -

    Reporting group title
    TPEX
    Reporting group description
    		 -

    Serious adverse events
    		 EXTREME TPEX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    143 / 265 (53.96%)
    118 / 263 (44.87%)
         number of deaths (all causes)
    243
    234
         number of deaths resulting from adverse events
    23
    16
    Blood and lymphatic system disorders
    Febril neutropenia
         subjects affected / exposed
    10 / 265 (3.77%)
    21 / 263 (7.98%)
         occurrences causally related to treatment / all
    10 / 10
    21 / 21
         deaths causally related to treatment / all
    6 / 6
    3 / 3
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    17 / 265 (6.42%)
    10 / 263 (3.80%)
         occurrences causally related to treatment / all
    17 / 17
    10 / 10
         deaths causally related to treatment / all
    3 / 3
    2 / 2
    Allergic reaction
         subjects affected / exposed
    10 / 265 (3.77%)
    5 / 263 (1.90%)
         occurrences causally related to treatment / all
    10 / 10
    5 / 5
         deaths causally related to treatment / all
    3 / 3
    2 / 2
    Fever
         subjects affected / exposed
    6 / 265 (2.26%)
    7 / 263 (2.66%)
         occurrences causally related to treatment / all
    6 / 6
    7 / 7
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Fatigue
         subjects affected / exposed
    8 / 265 (3.02%)
    3 / 263 (1.14%)
         occurrences causally related to treatment / all
    8 / 8
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    20 / 265 (7.55%)
    7 / 263 (2.66%)
         occurrences causally related to treatment / all
    20 / 20
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis oral
         subjects affected / exposed
    9 / 265 (3.40%)
    8 / 263 (3.04%)
         occurrences causally related to treatment / all
    9 / 9
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    8 / 265 (3.02%)
    4 / 263 (1.52%)
         occurrences causally related to treatment / all
    8 / 8
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 265 (1.51%)
    8 / 263 (3.04%)
         occurrences causally related to treatment / all
    4 / 4
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    2 / 265 (0.75%)
    7 / 263 (2.66%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection (any type)
         subjects affected / exposed
    41 / 265 (15.47%)
    37 / 263 (14.07%)
         occurrences causally related to treatment / all
    41 / 41
    37 / 37
         deaths causally related to treatment / all
    9 / 9
    8 / 8
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EXTREME TPEX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    264 / 265 (99.62%)
    263 / 263 (100.00%)
    Investigations
    Gamma glutamyl transferase increased
         subjects affected / exposed
    135 / 265 (50.94%)
    115 / 263 (43.73%)
         occurrences all number
    135
    115
    Serum albumine decreased
         subjects affected / exposed
    133 / 265 (50.19%)
    137 / 263 (52.09%)
         occurrences all number
    133
    137
    Alcaline phosphatase increased
         subjects affected / exposed
    66 / 265 (24.91%)
    64 / 263 (24.33%)
         occurrences all number
    66
    64
    Alanine aminotransferase increased
         subjects affected / exposed
    57 / 265 (21.51%)
    58 / 263 (22.05%)
         occurrences all number
    57
    58
    Aspartate aminotransferase increased
         subjects affected / exposed
    52 / 265 (19.62%)
    56 / 263 (21.29%)
         occurrences all number
    52
    56
    Creatinine renal clearance increased
         subjects affected / exposed
    115 / 265 (43.40%)
    64 / 263 (24.33%)
         occurrences all number
    115
    64
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    214 / 265 (80.75%)
    201 / 263 (76.43%)
         occurrences all number
    214
    201
    Neutropenia
         subjects affected / exposed
    121 / 265 (45.66%)
    67 / 263 (25.48%)
         occurrences all number
    121
    67
    Leucopenia
         subjects affected / exposed
    148 / 265 (55.85%)
    96 / 263 (36.50%)
         occurrences all number
    148
    96
    Febrile leucopenia
         subjects affected / exposed
    8 / 265 (3.02%)
    15 / 263 (5.70%)
         occurrences all number
    8
    15
    Trombocytopenia
         subjects affected / exposed
    148 / 265 (55.85%)
    96 / 263 (36.50%)
         occurrences all number
    148
    96
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    194 / 265 (73.21%)
    178 / 263 (67.68%)
         occurrences all number
    194
    178
    Fever
         subjects affected / exposed
    31 / 265 (11.70%)
    30 / 263 (11.41%)
         occurrences all number
    31
    30
    General physical health deterioration
         subjects affected / exposed
    19 / 265 (7.17%)
    11 / 263 (4.18%)
         occurrences all number
    19
    11
    Allergic reaction
         subjects affected / exposed
    1 / 265 (0.38%)
    9 / 263 (3.42%)
         occurrences all number
    1
    9
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    33 / 265 (12.45%)
    14 / 263 (5.32%)
         occurrences all number
    33
    14
    Hearing impairment or hypo acusia
         subjects affected / exposed
    30 / 265 (11.32%)
    10 / 263 (3.80%)
         occurrences all number
    30
    10
    Gastrointestinal disorders
    Mucositis oral
         subjects affected / exposed
    152 / 265 (57.36%)
    118 / 263 (44.87%)
         occurrences all number
    152
    118
    Nausea
         subjects affected / exposed
    173 / 265 (65.28%)
    135 / 263 (51.33%)
         occurrences all number
    173
    135
    Vomiting
         subjects affected / exposed
    116 / 265 (43.77%)
    83 / 263 (31.56%)
         occurrences all number
    116
    83
    Diarrhoea
         subjects affected / exposed
    93 / 265 (35.09%)
    116 / 263 (44.11%)
         occurrences all number
    93
    116
    Constipation
         subjects affected / exposed
    76 / 265 (28.68%)
    61 / 263 (23.19%)
         occurrences all number
    76
    61
    Dysphagia
         subjects affected / exposed
    48 / 265 (18.11%)
    33 / 263 (12.55%)
         occurrences all number
    48
    33
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    30 / 265 (11.32%)
    21 / 263 (7.98%)
         occurrences all number
    30
    21
    Skin and subcutaneous tissue disorders
    Rash acneiform
         subjects affected / exposed
    166 / 265 (62.64%)
    167 / 263 (63.50%)
         occurrences all number
    166
    167
    Dry skin
         subjects affected / exposed
    72 / 265 (27.17%)
    74 / 263 (28.14%)
         occurrences all number
    72
    74
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    36 / 265 (13.58%)
    28 / 263 (10.65%)
         occurrences all number
    36
    28
    Alopecia
         subjects affected / exposed
    31 / 265 (11.70%)
    59 / 263 (22.43%)
         occurrences all number
    31
    59
    Infections and infestations
    Infection any type
         subjects affected / exposed
    72 / 265 (27.17%)
    77 / 263 (29.28%)
         occurrences all number
    72
    77
    Metabolism and nutrition disorders
    Magnesium metabolism disorder
         subjects affected / exposed
    161 / 265 (60.75%)
    147 / 263 (55.89%)
         occurrences all number
    161
    147
    Potassium disorders
         subjects affected / exposed
    162 / 265 (61.13%)
    129 / 263 (49.05%)
         occurrences all number
    162
    129
    Calcium disorders
         subjects affected / exposed
    144 / 265 (54.34%)
    145 / 263 (55.13%)
         occurrences all number
    144
    145
    Sodium disorders
         subjects affected / exposed
    139 / 265 (52.45%)
    125 / 263 (47.53%)
         occurrences all number
    139
    125
    Phosphorus metabolism disorder
         subjects affected / exposed
    137 / 265 (51.70%)
    127 / 263 (48.29%)
         occurrences all number
    137
    127
    Hyperglycaemia
         subjects affected / exposed
    61 / 265 (23.02%)
    48 / 263 (18.25%)
         occurrences all number
    61
    48
    Anorexia
         subjects affected / exposed
    84 / 265 (31.70%)
    86 / 263 (32.70%)
         occurrences all number
    84
    86
    Weight loss
         subjects affected / exposed
    58 / 265 (21.89%)
    52 / 263 (19.77%)
         occurrences all number
    58
    52

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2014
    - Change of principal investigator - Addition of further investigational sites in France
    14 Jan 2015
    - Addition of an exclusion criterion concerning concomitant malignancies - Addition of details concerning the commercially availability of the study treatments, premedications, concomitant treatments, and GCSF - Adjustment of the General Guidelines for the cetuximab administration both during chemotherapy and maintenance - Addition of details concerning the cisplatin administration both in the EXTREME arm and in the TPEx arm - Addition of details concerning the 5FUand docetaxel administration - Addition of details concerning the assessments to be performed during the study - Addition of details concerning the QoL assessments to be performed during the study follow-up if a patient was withdrawn from study treatment - Addition of details concerning the QoL assessments to be performed during the study follow-up if a patient was withdrawn from study treatment - Clarification on the definition of the G1 hypercreatinemia according to the NCI CTCAE V4.03 and on the actions to be taken concerning the chemotherapy administration
    09 Jun 2015
    - Modification of the Exclusion Criterion concerning the concomitant radiotherapy within 6 weeks before study entry - Addition of two Exclusion Criteria - Addition in the section 2.2 of details concerning the EMR 62202-008 phase I/II study and EXTREME study on standard treatment in recurrent and/or metastatic HNSCC. - Clarification on the use of carboplatin (as part of the EXTREME regimen) for patients not able to receive cisplatin. - Clarifications on the medical, financial, or ethical reasons for study discontinuation - Addition of note in the Flow-Chart clarifying the coagulation tests to be done(Prothrombin time, INR, and aPTT). - Clarification that deaths caused by disease progression more than 30 days after the end ofstudy treatment were not considered as SAEs and were excluded from expedited reporting. -Update of the bibliographic references.
    17 Jan 2017
    - Addition of a statistical analysis of futility. -Addition of further 124 patients to be included in the study in order to increase the powerof study from 80% to 88% as consequence of the addition of a statistical analysis of futility

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Dec 2021
    The sponsor has decided to set the LPLV at 31/12/2021 and to censor the last patients still undergoing treatment on this date. Indeed, the protocol provided for a maintenance period continuing until toxicity or progression. Also, 5 patients were still being treated at this date, making it impossible to perform the final analysis of this trial. The management of these patients continues according to a standard protocol. They will therefore be considered as “long survivors” for this analysis. In addition, the last patient was included in the trial on 13/11/2017, the chosen LPLV therefore ensures a sufficiently long follow-up period, i.e. 4 years. post last inclusion. Furthermore, during this decision, the sponsor was aware that more than 80% of the patients included in the trial had died. The vital status of all patients will be collected on 31/12/2021
    -

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