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

Conditions: extra cranial non seminomateous malignant germ cell tumour in child, adolescent and young adult
MedDRA version: 18.0Level: LLTClassification code 10049516Term: Malignant tumorSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-004039-60-FR

Lead Sponsor: CENTRE LEON BERARD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the progression-free survival in patients with extra cranial non seminomateous malignant germ cell tumor (NSMGCT) and treated with chemiotherapy;Secondary Objective: -To evaluate the rate of patients with complete remission after 1st line treatment<br>-To evaluate the progression-free survival of patients with complete remission after 1st line treatment<br>-To evaluate the overall survival (OS) of high-risk patients (age > 10 years, testicular or extragonadal NSMGCT and/or hCG > 5000 UI/l)<br>-To study long-term effects of the treatment;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: 2 years following the last patient enrolment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - rate of patients in complete remission after first line treatment<br>- progression-free survival of patients with complete remission after 1st line treatment<br>- overall survival (OS) of high-risk patients (age > 10 years, testicular or extragonadal NSMGCT and/or hCG > 5000 UI/l)<br>-Late toxicities according to NCI-CTCAE v4 or Brock grading for hearing impairment;Timepoint(s) of evaluation of this end point: max 5 years after last patient inclusion