A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
Overview
- Phase
- Phase 2
- Intervention
- Velbe-Bleomycin-Cisplatin
- Conditions
- Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
- Sponsor
- Centre Leon Berard
- Enrollment
- 117
- Locations
- 10
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
3 courses of Velbe-Bleomycin-Cisplatin
3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Intervention: Velbe-Bleomycin-Cisplatin
4 courses of Velbe-Bleomycin-Cisplatin
4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Intervention: Velbe-Bleomycin-Cisplatin
3 courses Vepeside-ifosfamide-Cisplatin
3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Intervention: Vepeside-ifosfamide-Cisplatin
4 courses Vepeside-ifosfamide-Cisplatin
4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Intervention: Vepeside-ifosfamide-Cisplatin
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 24 months
Secondary Outcomes
- 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))