A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

Study Overview
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Brief Summary
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The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.

Detailed Description
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Two different situations will be considered: in NSMGCT patients treated with cisplatin-based chemotherapy, the objective is to maintain a 2-year progression-free survival rate >80% despite a limitation of the number of course of chemotherapy (≤4) after the achievement of a clinical and biological response (primary endpoint); in children over 10 years with testicular or extragonadal NSMGCT, the objective is to improve the overall survival by systematically classifying the patients in high-risk group to allow a dose intensification.

Official Title
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A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

Conditions
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Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Intervention / Treatment
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* Drug: Velbe-Bleomycin-Cisplatin
* Drug: Vepeside-ifosfamide-Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extra cranial non seminomateous malignant germ cell tumour (NSMGCT) except pure immature teratoma. Age ≤ 18 years. Affiliation with a social security scheme. Signed informed consent by parents Effective contraception during the study if relevant . Exclusion Criteria: Previous chemotherapy Contraindications to study treatments Patient who cannot follow medical surveillance due to geographical, social, or psychological reasons Pregnant and breast feeding women

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 courses of Velbe-Bleomycin-Cisplatin<br>3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses | Drug: Velbe-Bleomycin-Cisplatin<br>* Limitation of the number of chemotherapy courses (≤ 4) after the achievement of a clinical and biological response in NSMGCT patients treated with cisplatin-based chemotherapy, in order to reduce treatment long-term effects<br>* Other names: Desescalation;|
| Experimental: 4 courses of Velbe-Bleomycin-Cisplatin<br>4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses | Drug: Velbe-Bleomycin-Cisplatin<br>* Limitation of the number of chemotherapy courses (≤ 4) after the achievement of a clinical and biological response in NSMGCT patients treated with cisplatin-based chemotherapy, in order to reduce treatment long-term effects<br>* Other names: Desescalation;|
| Experimental: 3 courses Vepeside-ifosfamide-Cisplatin<br>3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses | Drug: Vepeside-ifosfamide-Cisplatin<br> <br> |
| Experimental: 4 courses Vepeside-ifosfamide-Cisplatin<br>4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses | Drug: Vepeside-ifosfamide-Cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Within 10 years after the first inclusion, from the date of inclusion to the date of death due to any cause | 
| complete remission rate after 1st line treatment (chemotherapy and surgery) |  | 3 weeks after the end of treatment (CT + surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non seminomateous malignant germ cell tumour (NSMGCT), Dose De-escalation, Chemotherapy