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

Phase 2

Completed

• Conditions: Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
• Interventions: Drug: Velbe-Bleomycin-Cisplatin; Drug: Vepeside-ifosfamide-Cisplatin

• Registration Number: NCT02104986
• Lead Sponsor: Centre Leon Berard

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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Study Start: 2014-05-12
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 courses of Velbe-Bleomycin-Cisplatin	Velbe-Bleomycin-Cisplatin	3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
4 courses of Velbe-Bleomycin-Cisplatin	Velbe-Bleomycin-Cisplatin	4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
3 courses Vepeside-ifosfamide-Cisplatin	Vepeside-ifosfamide-Cisplatin	3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
4 courses Vepeside-ifosfamide-Cisplatin	Vepeside-ifosfamide-Cisplatin	4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses

Primary Outcome Measures

Name	Time	Method
Progression-free survival	24 months

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (10)

Centre Oscar Lambret; 🇫🇷 Lille, France

Hopital de La Timone; 🇫🇷 Marseille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hopital Felix Guyon; 🇫🇷 Saint Denis, France

CHRU; 🇫🇷 Tours, France

CHU; 🇫🇷 Toulouse, France

Institut Curie; 🇫🇷 Paris, France

Chu Morvan; 🇫🇷 Brest, France

Chu Estaing; 🇫🇷 Clermont-ferrand, France

Hopital Trousseau; 🇫🇷 Paris, France