NCT02104986

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Interventions

Type	Name	Description
DRUG	Velbe-Bleomycin-Cisplatin	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
DRUG	Vepeside-ifosfamide-Cisplatin

Timeline

• Start date: 2014-05-12
• Primary completion: 2021-10-14
• Completion: 2021-10-14
• First posted: 2014-04-07
• Last updated: 2022-08-29

Locations

27 sites across 1 country: France