A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
August 26, 2022 updated by: Centre Leon Berard
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU
-
Angers, France, 49033
- CHU
-
Besançon, France, 25030
- CHRU
-
Bordeaux, France, 33076
- CHU
-
Brest, France, 26609
- CHU Morvan
-
Caen, France, 14033
- CHU
-
Clermont-ferrand, France, 63003
- CHU Estaing
-
Dijon, France, 21079
- CHU
-
Lille, France, 59000
- Centre Oscar Lambret
-
Limoges, France, 87042
- CHU
-
Marseille, France, 13385
- Hôpital de la Timone
-
Montpellier, France, 34295
- CHU
-
Nancy, France, 54511
- CHU
-
Nantes, France, 44093
- CHU
-
Nice, France, 06202
- CHU
-
Paris, France, 75005
- Institut Curie
-
Paris, France, 75012
- Hôpital TROUSSEAU
-
Poitiers, France, 86021
- CHU
-
Reims, France, 51092
- CHU
-
Rennes, France, 35203
- CHU
-
Rouen, France, 76031
- CHU
-
Saint Denis, France, 97405
- Hôpital Félix Guyon
-
Saint Etienne, France, 42055
- CHRU
-
Strasbourg, France, 67098
- CHRU
-
Toulouse, France, 31059
- CHU
-
Tours, France, 37044
- CHRU
-
Villejuif, France, 94805
- Institut Gustave Roussy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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:
|
|
Experimental: 4 courses of Velbe-Bleomycin-Cisplatin
4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
|
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:
|
|
Experimental: 3 courses Vepeside-ifosfamide-Cisplatin
3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
|
|
|
Experimental: 4 courses Vepeside-ifosfamide-Cisplatin
4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-free survival
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: Within 10 years after the first inclusion, from the date of inclusion to the date of death due to any cause
|
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)
Time Frame: 3 weeks after the end of treatment (CT + surgery)
|
3 weeks after the end of treatment (CT + surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cécile CONTER, MD, Centre Léon Bérard, Lyon, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2014
Primary Completion (Actual)
October 14, 2021
Study Completion (Actual)
October 14, 2021
Study Registration Dates
First Submitted
March 27, 2014
First Submitted That Met QC Criteria
April 2, 2014
First Posted (Estimate)
April 7, 2014
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TGM 2013-NS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.