Clinical trial NCT02104986: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
Official title: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
Keywords: non seminomateous malignant germ cell tumour (NSMGCT)
Dose De-escalation
Chemotherapy
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 117
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: Within 10 years after the first inclusion, from the date of inclusion to the date of death due to any cause
measure: complete remission rate after 1st line treatment (chemotherapy and surgery)
timeFrame: 3 weeks after the end of treatment (CT + surgery)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Angers
country: France
facility: CHU
city: Besançon
country: France
facility: CHRU
city: Bordeaux
country: France
facility: CHU
city: Brest
country: France
facility: Chu Morvan
city: Caen
country: France
facility: CHU
city: Clermont-ferrand
country: France
facility: Chu Estaing
city: Dijon
country: France
facility: CHU
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: CHU
city: Marseille
country: France
facility: Hopital de La Timone
city: Montpellier
country: France
facility: CHU
city: Nancy
country: France
facility: CHU
city: Nantes
country: France
facility: CHU
city: Nice
country: France
facility: CHU
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Trousseau
city: Poitiers
country: France
facility: CHU
city: Reims
country: France
facility: CHU
city: Rennes
country: France
facility: CHU
city: Rouen
country: France
facility: CHU
city: Saint Denis
country: France
facility: Hopital Felix Guyon
city: Saint Etienne
country: France
facility: CHRU
city: Strasbourg
country: France
facility: CHRU
city: Toulouse
country: France
facility: CHU
city: Tours
country: France
facility: CHRU
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Léon Bérard, Lyon, FRANCE
name: Cécile CONTER, MD
role: PRINCIPAL_INVESTIGATOR
References: