A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
NCT ID: NCT02104986
Last Updated: 2022-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2014-05-12
2021-10-14
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3 courses of Velbe-Bleomycin-Cisplatin
3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
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
4 courses of Velbe-Bleomycin-Cisplatin
4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
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
3 courses Vepeside-ifosfamide-Cisplatin
3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Vepeside-ifosfamide-Cisplatin
4 courses Vepeside-ifosfamide-Cisplatin
4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Vepeside-ifosfamide-Cisplatin
Interventions
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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
Vepeside-ifosfamide-Cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≤ 18 years.
* Affiliation with a social security scheme.
* Signed informed consent by parents
* Effective contraception during the study if relevant .
Exclusion Criteria
* Contraindications to study treatments
* Patient who cannot follow medical surveillance due to geographical, social, or psychological reasons
* Pregnant and breast feeding women
18 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Cécile CONTER, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Léon Bérard, Lyon, FRANCE
Locations
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CHU
Amiens, , France
CHU
Angers, , France
CHRU
Besançon, , France
CHU
Bordeaux, , France
Chu Morvan
Brest, , France
CHU
Caen, , France
Chu Estaing
Clermont-Ferrand, , France
CHU
Dijon, , France
Centre Oscar Lambret
Lille, , France
CHU
Limoges, , France
Hopital de La Timone
Marseille, , France
CHU
Montpellier, , France
CHU
Nancy, , France
CHU
Nantes, , France
CHU
Nice, , France
Institut Curie
Paris, , France
Hopital Trousseau
Paris, , France
CHU
Poitiers, , France
CHU
Reims, , France
CHU
Rennes, , France
CHU
Rouen, , France
Hopital Felix Guyon
Saint-Denis, , France
CHRU
Saint-Etienne, , France
CHRU
Strasbourg, , France
CHU
Toulouse, , France
CHRU
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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TGM 2013-NS
Identifier Type: -
Identifier Source: org_study_id
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