A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
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ClinicalTrials.gov Identifier: NCT02104986 |
Recruitment Status :
Active, not recruiting
First Posted : April 7, 2014
Last Update Posted : October 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Extra Cranial Non Seminomateous Malignant Germ Cell Tumour | Drug: Velbe-Bleomycin-Cisplatin Drug: Vepeside-ifosfamide-Cisplatin | Phase 2 |
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 (Clinical Trial) |
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 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | May 2024 |

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 Name: 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 Name: 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 |
- Progression-free survival [ Time Frame: 24 months ]
- 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 ]
- complete remission rate after 1st line treatment (chemotherapy and surgery) [ Time Frame: 3 weeks after the end of treatment (CT + surgery) ]

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104986

Principal Investigator: | Cécile CONTER, MD | Centre Léon Bérard, Lyon, FRANCE |
Responsible Party: | Centre Leon Berard |
ClinicalTrials.gov Identifier: | NCT02104986 |
Other Study ID Numbers: |
TGM 2013-NS |
First Posted: | April 7, 2014 Key Record Dates |
Last Update Posted: | October 15, 2021 |
Last Verified: | October 2021 |
non seminomateous malignant germ cell tumour (NSMGCT) Dose De-escalation Chemotherapy |
Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms by Histologic Type Cisplatin Ifosfamide Bleomycin |
Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic |