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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
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Study Description
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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
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. complete remission rate after 1st line treatment (chemotherapy and surgery) [ Time Frame: 3 weeks after the end of treatment (CT + surgery) ]

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

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
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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


Locations
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Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Cécile CONTER, MD Centre Léon Bérard, Lyon, FRANCE
More Information
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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
Keywords provided by Centre Leon Berard:
non seminomateous malignant germ cell tumour (NSMGCT)
Dose De-escalation
Chemotherapy
Additional relevant MeSH terms:
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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