Overview

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:
Active, not recruiting
Trial end date:
2024-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Leon Berard
Treatments:
Bleomycin
Cisplatin
Ifosfamide
Isophosphamide mustard
Vinblastine
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