Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU, Amiens, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Velbe-Bleomycin-Cisplatin

Drug

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

Other names: Desescalation

Vepeside-ifosfamide-Cisplatin

Drug

Primary outcomes

  1. Progression-free survival

    Time frame: 24 months

Secondary outcomes

  1. 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

  2. complete remission rate after 1st line treatment (chemotherapy and surgery)

    Time frame: 3 weeks after the end of treatment (CT + surgery)

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2014
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.