A study to evaluate a risk-adapted treatment of extra cranial malignant germ cell in children, adolescent and young adult

Phase 1

• Conditions: extra cranial non seminomateous malignant germ cell tumour in child, adolescent and young adult; MedDRA version: 21.0 Level: LLT Classification code 10049516 Term: Malignant tumor System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004039-60-BE
• Lead Sponsor: CENTRE LEON BERARD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 94

Inclusion Criteria

I1.Age = 18 years
I2.Extra cranial non seminomateous malignant germ cell tumour (NSMGCT) except pure immature teratoma
I3.Signed informed consent by patient if age = 18 or by parents or legal guardian and child if possible
I4.Affiliation with a social security scheme.
I5. Effective contraception during the whole treatment and during 6 months after treatment for pubescent children when relevant

Are the trial subjects under 18? yes
Number of subjects for this age range: 94
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

E1. Prior treatment with chemoterapy for this tumour
E2. Contra indication to planned treatments (cf. smPC)
E3. not possible long-term follow-up
E4. pregnant or breasfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified