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    Clinical Trial Results:
    A multicenter study to evaluate a risk-adapted strategy for treatment of extra cranial non seminomateous malignant germ cell tumour in children, adolescent and young adult

    Summary
    EudraCT number
    		 2013-004039-60
    Trial protocol
    		 FR   BE  
    Global end of trial date
    14 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2025
    First version publication date
    24 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ET13-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02104986
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 rue Laennec, Lyon, France, 69008
    Public contact
    Ellen BLANC, Centre Léon Bérard, +33 (0)4 78 78 28 28,
    Scientific contact
    Dr Cécile FAURE-CONTER , Centre Léon Bérard, +33 (0)4 78 78 28 28,
    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
    28 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the progression-free survival in patients with extra cranial non seminomateous malignant germ cell tumor (NSMGCT) and treated with chemiotherapy
    Protection of trial subjects
    The investigator proceeded to the following information/procedures during the screening visit: - Fully inform the patient of the study treatments, the objectives and the design of the study, answer to any questions that the patient may have and ensure that the patient understands the potential risks and benefits of participating in the study before signing the informed consent form. None study-related procedure can be started before ICF is signed and dated by both the patient (and impartial witness, if applicable). - Check the eligibility criteria list and perform the exams
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 30 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 112
    Worldwide total number of subjects
    115
    EEA total number of subjects
    115
    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)
    25
    Children (2-11 years)
    23
    Adolescents (12-17 years)
    52
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at the time of enrolment at the participating sites. The declared investigator, after having identified a potential candidate for the study, informed her orally of the terms of the study and provide her with : an information note, An informed consent form that has been dated and signed by the patient and the investigator.

    Pre-assignment
    Screening details
    		 None study-related procedure can be started before ICF was signed and dated by both the patient (and impartial witness, if applicable) and the investigator - Checked the eligibility criteria list and perform the exams.

    Period 1
    Period 1 title
    Overrall period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group IR1
    Arm description
    		 Chemotherapy consists of 3 cycles of VBP (Vinblastine, Bleomycin, Cisplatin) and can be administered as an adjuvant to surgery or as neoadjuvant therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vinblastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Vinblastine 3 mg/m²/j IVD at D1 + D2

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bleomycin 15 mg/m²/day IV 6 hours (UI = mg) at D1 + D2

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 33 mg/m²/day - IV 3 hours at D3 + D4 + D5

    Arm title
    		 Group IR2
    Arm description
    		 Chemotherapy consists of 4 courses of VBP (Vinblastin, Bleomycin, Cisplatin) and can be administered as an adjuvant to surgery or as neoadjuvant therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vinblastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Vinblastine 3 mg/m²/day IVD at D1+ D2

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bleomycin 15 mg/m²/day IV 6 hours (UI = mg) at D1 + D2

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 33 mg/m²/day - IV 3 hours at D3 + D4 + D5

    Arm title
    		 Group HR1
    Arm description
    		 Chemotherapy consists of 3 cycles of VIP (Vepedid/Etoposide, Ifosfamid, Cisplatin), (or BEP (Bleomycin, Etoposid, Cisplatin) if the patient is pubertal) and can be administered as an adjuvant to surgery or as a neoadjuvant.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vepesid
    Investigational medicinal product code
    Other name
    Etoposide
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide 75 mg/m²/day – IV 2 hours at D1 + D2 + D3 + D4 + D5

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ifosfamide 3 g/m²/day – IV 3 hours at D1 + D2

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 20 mg/m²/day - IV 3 hours at D1 + D2 + D3 + D4 + D5

    Arm title
    		 Group HR2
    Arm description
    		 Chemotherapy consists of 4 cycles of VIP (Vepedid/Etoposide, Ifosfamid, Cisplatin), (or BEP (Bleomycin, Etoposid, Cisplatin) if the patient is pubertal) and can be administered as an adjuvant to surgery or as a neoadjuvant.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vepesid
    Investigational medicinal product code
    Other name
    Etoposide
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide 75 mg/m²/j – IV 2 heures at D1 + D2 + D3 + D4 + D5

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ifosfamide 3 g/m²/day – IV 3 hours at D1 + D2

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 20 mg/m²/day - IV 3 hours at D1 + D2 + D3 + D4 + D5

    Number of subjects in period 1
    		Group IR1 Group IR2 Group HR1 Group HR2
    Started
    20
    11
    30
    54
    Completed
    20
    11
    30
    54

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overrall period
    Reporting group description
    		 No inclusion or exclusion criteria violation were recorded. For 3 patients, treatment recommendations were not respected and these patients were excluded from the cohort. The final population analysis described in this report is 115 patients.

    Reporting group values
    		 Overrall period Total
    Number of subjects
    		 115 115
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 26 26
        Children (2-11 years)
    		 33 33
        Adolescents (12-17 years)
    		 41 41
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 12.8 (0.4 to 18.9) -
    Gender categorical
    Units: Subjects
        Female
    		 68 68
        Male
    		 47 47
    Subject analysis sets

    Subject analysis set title
    Overall period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    No inclusion or exclusion criteria violation were recorded. For 3 patients, treatment recommendations were not respected and these patients were excluded from the cohort. The final population analysis described in this report is 115 patients.

    Subject analysis sets values
    		 Overall period
    Number of subjects
    115
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    24
        Children (2-11 years)
    23
        Adolescents (12-17 years)
    53
        Adults (18-64 years)
    15
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    12.8 (0.4 to 18.9)
    Gender categorical
    Units: Subjects
        Female
    68
        Male
    47

    End points

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    End points reporting groups
    Reporting group title
    Group IR1
    Reporting group description
    		 Chemotherapy consists of 3 cycles of VBP (Vinblastine, Bleomycin, Cisplatin) and can be administered as an adjuvant to surgery or as neoadjuvant therapy.

    Reporting group title
    Group IR2
    Reporting group description
    		 Chemotherapy consists of 4 courses of VBP (Vinblastin, Bleomycin, Cisplatin) and can be administered as an adjuvant to surgery or as neoadjuvant therapy.

    Reporting group title
    Group HR1
    Reporting group description
    		 Chemotherapy consists of 3 cycles of VIP (Vepedid/Etoposide, Ifosfamid, Cisplatin), (or BEP (Bleomycin, Etoposid, Cisplatin) if the patient is pubertal) and can be administered as an adjuvant to surgery or as a neoadjuvant.

    Reporting group title
    Group HR2
    Reporting group description
    		 Chemotherapy consists of 4 cycles of VIP (Vepedid/Etoposide, Ifosfamid, Cisplatin), (or BEP (Bleomycin, Etoposid, Cisplatin) if the patient is pubertal) and can be administered as an adjuvant to surgery or as a neoadjuvant.

    Subject analysis set title
    Overall period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    No inclusion or exclusion criteria violation were recorded. For 3 patients, treatment recommendations were not respected and these patients were excluded from the cohort. The final population analysis described in this report is 115 patients.

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    2 years ≥ 80% despite a limit on the number of courses of treatment to 4 if a complete clinical and biological biological remission
    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: After a median follow-up of 42.7 months (95% CI = 39–50.1) following the first cycle of chemotherapy, 11 patients progressed (9.6%) and 6 deaths (5.2%) were reported. The 2-year progression-free survival rate was 89% (95% CI = 81–93). As a reminder, the study objective was to observe a 2-year progression-free survival rate greater than 80%. The 2-year overall survival rate was 95% (95% CI = 89–98).
    End point values
    		 Overall period
    Number of subjects analysed
    115
    Units: 2 years ≥ 80%
    115
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The most frequently observed adverse events in the study were: decreased neutrophil count (20.9%), post-chemotherapy vomiting (12.2%), neutropenia (12.2%), and febrile aplasia (12.2%). Nineteen patients (16.5%) had abnormal hearing during follow-up, but 8 of them experienced hearing recovery.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 May 2014
    -Update the list of investigators. - Protocol modification (MNS)
    22 Sep 2014
    Update the list of investigators
    17 Feb 2015
    - Update the list of investigators ; - Inform of a reformulation of the definition of SAEs not requiring immediate reporting by the investigator.
    20 Sep 2015
    - Update the list of investigators ; - Change in RCP used as reference for safety information on bleomycin.
    05 Apr 2016
    Update the list of investigators ; Change RCP
    12 Dec 2017
    -Update the list of investigators. - Protocol modification (MNS)
    27 Mar 2018
    Update the list of investigators
    13 Nov 2018
    - Pharmacovigilance section updated; - Study documents brought into compliance with the General Data Protection Regulation (GDPR); - Investigator list updated:
    09 Jul 2019
    Update the list of the investigators
    13 Oct 2021
    - Reducing the follow-up time for patients from 5 years to a minimum of 2.5 years ; - Modification of the phase of the study (phase II instead of III) ; - Other non-substantial changes to the protocol.

    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
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