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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02104986

Enrollment

117

Registered

2014-04-07

Start date

2014-05-12

Completion date

2021-10-14

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Keywords

non seminomateous malignant germ cell tumour (NSMGCT), Dose De-escalation, Chemotherapy

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.

Interventions

DRUGVelbe-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

DRUGVepeside-ifosfamide-Cisplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	24 months

Secondary

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026