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

A multicenter study to evaluate a risk-adapted strategy for treatment of extra cranial non seminomateous malignant germ cell tumour in children, adolescent and young adult - TGM 2013 - NS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004039-60-FR
Enrollment
Unknown
Registered
2015-09-16
Start date
2014-10-23
Completion date
Unknown
Last updated
2015-09-21

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 in child, adolescent and young adult MedDRA version: 18.0 Level: LLT Classification code 10049516 Term: Malignant tumor System Organ Class: 100000004864

Interventions

Product Name: cisplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: cisplatin Other descriptive name: CISPLATIN Concentration unit: mg/l milligram(s)/litre Concentration type: equa

Sponsors

CENTRE LEON BERARD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 -To evaluate the progression-free survival of patients with complete remission after 1st line treatment -To evaluate the overall survival (OS) of high-risk patients (age > 10 years, testicular or extragonadal NSMGCT and/or hCG > 5000 UI/l) -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

MeasureTime frame
Secondary end point(s): - rate of patients in complete remission after first line treatment - progression-free survival of patients with complete remission after 1st line treatment - overall survival (OS) of high-risk patients (age > 10 years, testicular or extragonadal NSMGCT and/or hCG > 5000 UI/l) -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—

Countries

France

Contacts

Public ContactDRCI - Pôle Opérations cliniques

CENTRE LEON BERARD

ellen.blanc@lyon.unicancer.fr+33(0)478 78 29 67

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 12, 2026