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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.
Two different situations will be considered:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 courses of Velbe-Bleomycin-Cisplatin | Experimental | 3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
|
| 4 courses of Velbe-Bleomycin-Cisplatin | Experimental | 4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
|
| 3 courses Vepeside-ifosfamide-Cisplatin | Experimental | 3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
|
| 4 courses Vepeside-ifosfamide-Cisplatin | Experimental | 4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velbe-Bleomycin-Cisplatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cécile CONTER, MD | Centre Léon Bérard, Lyon, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Amiens | 80054 | France | |||
| CHU |
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|
| Vepeside-ifosfamide-Cisplatin | Drug |
|
| Angers |
| 49033 |
| France |
| CHRU | Besançon | 25030 | France |
| CHU | Bordeaux | 33076 | France |
| Chu Morvan | Brest | 26609 | France |
| CHU | Caen | 14033 | France |
| Chu Estaing | Clermont-Ferrand | 63003 | France |
| CHU | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| CHU | Limoges | 87042 | France |
| Hopital de La Timone | Marseille | 13385 | France |
| CHU | Montpellier | 34295 | France |
| CHU | Nancy | 54511 | France |
| CHU | Nantes | 44093 | France |
| CHU | Nice | 06202 | France |
| Institut Curie | Paris | 75005 | France |
| Hopital Trousseau | Paris | 75012 | France |
| CHU | Poitiers | 86021 | France |
| CHU | Reims | 51092 | France |
| CHU | Rennes | 35203 | France |
| CHU | Rouen | 76031 | France |
| Hopital Felix Guyon | Saint-Denis | 97405 | France |
| CHRU | Saint-Etienne | 42055 | France |
| CHRU | Strasbourg | 67098 | France |
| CHU | Toulouse | 31059 | France |
| CHRU | Tours | 37044 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |