A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

Sponsor

Centre Leon Berard (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02104986

Collaborator

(none)

117

Enrollment

Locations

Arms

119.7

Anticipated Duration (Months)

4.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extra Cranial Non Seminomateous Malignant Germ Cell Tumour	Drug: Velbe-Bleomycin-Cisplatin Drug: Vepeside-ifosfamide-Cisplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 12, 2014

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 courses of Velbe-Bleomycin-Cisplatin 3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses	Drug: Velbe-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 Other Names: Desescalation
Experimental: 4 courses of Velbe-Bleomycin-Cisplatin 4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses	Drug: Velbe-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 Other Names: Desescalation
Experimental: 3 courses Vepeside-ifosfamide-Cisplatin 3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses	Drug: Vepeside-ifosfamide-Cisplatin
Experimental: 4 courses Vepeside-ifosfamide-Cisplatin 4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses	Drug: Vepeside-ifosfamide-Cisplatin

Outcome Measures

Primary Outcome Measures

Progression-free survival [24 months]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU	Amiens	France	80054
2	CHU	Angers	France	49033
3	CHRU	Besançon	France	25030
4	CHU	Bordeaux	France	33076
5	Chu Morvan	Brest	France	26609
6	CHU	Caen	France	14033
7	Chu Estaing	Clermont-ferrand	France	63003
8	CHU	Dijon	France	21079
9	Centre Oscar Lambret	Lille	France	59000
10	CHU	Limoges	France	87042
11	Hopital de La Timone	Marseille	France	13385
12	CHU	Montpellier	France	34295
13	CHU	Nancy	France	54511
14	CHU	Nantes	France	44093
15	CHU	Nice	France	06202
16	Institut Curie	Paris	France	75005
17	Hopital Trousseau	Paris	France	75012
18	CHU	Poitiers	France	86021
19	CHU	Reims	France	51092
20	CHU	Rennes	France	35203
21	CHU	Rouen	France	76031
22	Hopital Felix Guyon	Saint Denis	France	97405
23	CHRU	Saint Etienne	France	42055
24	CHRU	Strasbourg	France	67098
25	CHU	Toulouse	France	31059
26	CHRU	Tours	France	37044
27	Institut Gustave Roussy	Villejuif	France	94805