Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
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 Summary:
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.
Sponsor: Centre Leon Berard
Current Primary Outcome: Progression-free survival [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival [ Time Frame: 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) [ Time Frame: 3 weeks after the end of treatment (CT + surgery) ]
Original Secondary Outcome: Same as current
Information By: Centre Leon Berard
Dates:
Date Received: March 27, 2014
Date Started: May 2014
Date Completion: May 2024
Last Updated: March 30, 2016
Last Verified: March 2016
