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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-006638-38
    Sponsor's Protocol Code Number:2021/3282
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-03-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-006638-38
    A.3Full title of the trial
    A prospective program aiming at improving outcome for young adults with poor-prognosis non seminomatous germ-cell tumors - VAPOR (GETUG T06)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective program aiming at improving outcome for young adults with poor-prognosis non seminomatous germ-cell tumors - VAPOR (GETUG T06)
    A.3.2Name or abbreviated title of the trial where available
    VAPOR (GETUG T06)
    A.4.1Sponsor's protocol code number2021/3282
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGUSTAVE ROUSSY
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGUSTAVE ROUSSY
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGUSTAVE ROUSSY
    B.5.2Functional name of contact pointAqsa YAR
    B.5.3 Address:
    B.5.3.1Street Address114 RUE EDOUARD VAILLANT
    B.5.3.2Town/ cityVILLEJUIF
    B.5.3.3Post code94850
    B.5.3.4CountryFrance
    B.5.4Telephone number33142116717
    B.5.5Fax number33142116290
    B.5.6E-mailaqsa.yar@gustaveroussy.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Etoposide Accord 20mg/mL, solution à diluer pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE FRANCE SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEtoposide
    D.3.2Product code 3400955050001
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    Intravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CARBOPLATINE KABI 10mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCARBOPLATINE KABI
    D.3.2Product code 3400958386015
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-seminomatous germ-cell tumors (including testis, retroperitoneal and mediastinal primaries) with a disseminated disease (clinical stages II or III according to AJCC 8th edition) and classified as poor prognosis according to IGCCCG criteria
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this prospective research program that aims at improving outcome for young adults with poor-prognosis NSGCT is to validate prospectively the efficacy and safety of a personalized treatment based on early tumor marker kinetic assessment in real life for patients with poor-prognosis NSGCT.
    E.2.2Secondary objectives of the trial
    Secondary objective 1: to prospectively collect tissue samples from patients with poor-prognosis NSGCT
    Secondary objective 2: to assess the efficacy and safety of early surgery and/or high-dose chemotherapy with transplant in patients with a mediastinal NSGCT and an unfavorable decline
    Secondary objective 3: to assess whether an early systematic brain magnetic resonance imaging (MRI) can identify and allow treat better patients with asymptomatic oligo-brain metastases
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male patient older than 16 years old on day of signing informed consent
    2. Patient with evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum hCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated)
    3. Patient with testicular, retroperitoneal, or mediastinal primary site
    4. Patient with evidence of disseminated disease (clinical stages II or III according to AJCC 8th edition)
    5. Patient with disease classified as poor prognosis according to IGCCCG criteria:
    - Primary mediastinal NSGCT or,
    - Non-pulmonary visceral metastases or,
    - hCG > 50 000 UI/L, or AFP > 10 000 ng/mL, or LDH > 10 times the upper normal value
    6. Patient with adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 60 mL/min. Cockcroft formula: CrCl = [(140-age) x weight in kg]/[72 x serum creatinine (mg/dL)]
    7. Patient with absolute granulocyte count >= 1,500/mm3, platelets >= 100 000 mm3, bilirubine >= 1.5x the upper limit of normal value.
    8. Patient with a contra-indication of undergoing any brain MRI are eligible, but will not be part of the diagnostic study part
    9. Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the informed consent form
    10. Patient affiliated to social security system or beneficiary of the same
    11. Male of child-bearing potential, must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.
    Inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle)
    1. Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the specific Phase II informed consent form
    2. Patient with mediastinal primary site
    3. Patient with unfavorable serum marker decrease evaluated at D18-D21 of the first BEP-chemotherapy
    E.4Principal exclusion criteria
    Non-inclusion criteria common to the whole population
    1. Patient infected by the Human Immunodeficiency Virus (HIV)
    2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
    3. Patient with prior chemotherapy. Patients who have received a first cycle of cisplatin-base chemotherapy for their poor-prognosis NSGCT are eligible as far as tumor marker decline can be assessed at day 18-21.
    4. Patient with previous malignancy, except for basal-cell carcinoma of the skin
    5. Known allergy or hypersensitivity to any of the study drugs

    Non inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle)
    1. Patient (and his legal guardian for under-18 patient) who withdraws his consent
    2. Patient with Human T-cell Leukemia Virus (HTLV) type 1 and 2
    3. Patient with Hepatitis B surface antigen
    4. Patient with Hepatitis C antibody
    5. Patient with prior high-dose chemotherapy (HDCT) plus hematopoietic stem cell HSCs transplant
    E.5 End points
    E.5.1Primary end point(s)
    The primary evaluation criterion of the study is progression-free survival (PFS).
    PFS will be determined from the first day of the first cycle of BEP to the date of progression or death due to any cause, whichever occurs first.

    Progression will be defined as:
    - an increase in tumor markers (hCG and/or AFP) confirmed on two successive measures (except during the first two weeks of chemotherapy, because of the release phenomenon), or
    - a radiographic progression, based on conventional imaging (CT scan).

    In case of suspiscion of a growing teratoma syndrome (enlarging metastatic masses despite appropriate systemic chemotherapy and normalized serum markers), a pathological exam of the suspected lesions will be performed to confirm or infirm the diagnosis. A growing teratoma syndrome will be reported but not be considered as an event.
    E.5.2Secondary end point(s)
    Efficacy
    Response criteria
    Best tumor response will be assessed at the end of treatment (after chemotherapy or after surgery of residual masses, if any).

    - Patients with normal tumor markers and no clinical or radiologic evidence of disease will be classified as having achieved complete response to chemotherapy (cCR).

    - Patients with normal tumor markers and completely resected residual masses containing only necrosis or teratoma wil be classified as having achieved pathologic complete response (pCR).

    - Patients with normal tumor markers and completely resected masses containing viable cancer will be classified as having achieved surgical complete response (sCR).

    - Patients with incomplete resection of residual masses and normalized markers will be classified as partial response (PRm-).

    - Patients with incomplete resection of residual masses and non-normalized markers will be classified as partial response (PRm+).

    All other responses will be considered incomplete responses.

    Progressive disease (PD) is defined as an increase in tumor markers (hCG and/or AFP) confirmed on two successive measures (except during the first two weeks of chemotherapy, because of the release phenomenon), or a radiographic progression, based on conventional imaging (CT scan).

    Overall survival (OS)
    OS is defined as the time from the first day of the first cycle of BEP to the date of death due to any cause

    Tolerance

    Toxicity: All toxicities will be evaluated and recorded based on the NCI common toxicity criteria (CTCAE v5.0). They will be described by frequency and grade, by cycle and over all cycles, with the maximum grade over all cycles used as the summary measure for each patient.

    We will use this prospective trial to validate that only a very limited number of these curable patients develop severe toxicity (specifically long-term neurotoxicity, secondary leukemia).


    Treatment-related mortality: Treatment-related mortality will be defined as any death occurring during the course of chemotherapy or surgery, or within 30-days following the end of treatment.

    Quality of life – Patient-related outcomes
    The following questionnaires will be used: QLQ-C30, QLQ-TC26, FACT-GOG-NTX and IPQ


    Specific endpoints for the diagnostic study assessing the addition of an early systematic brain MRI:

    - The proportion of initially brain metastases-free patients who are diagnosed with brain metastases early on a systematic brain MRI performed at the middle of the therapeutic strategy. This proportion will be calculated with its exact 95% confidence interval.
    - The type of relapse (brain only vs brain + other site) among patients who will develop brain metastases
    - The proportion of these patients amenable to cure
    - The local treatments received, including potential complications of these treatments
    - The survival after brain metastases relapse
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the Last Patient Last Visit (LPLV). LPLV is defined as the date of the last protocol-specified visit/assessment for the last subject during the follow-up period or the last attempt by the Investigator to schedule this visit for the last patient. In patients with unfavorable serum marker decrease and testicular (...) decrease and mediastinal primary tumor, it refers to 9.5 years after inclusion of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 15
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the specific Phase II informed consent form
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After completion of the therapy, patients are to be followed for 9 years (..)
    The following examinations will be performed:
    -clinical examination
    -Quality of life questionnaires (...) once a year until the 5th year thereafter.
    -serum hCG, AFP, LDH, creatinine, and blood count
    -T scan of the initially involved sites until the 4th year,(...) every 2 years until the 9th year
    -Note that a testis ultrasound is recommended (..)once a year until the 5th year, and once every 2 years thereafter
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-18
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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