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

Conditions

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

  • France
      • 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
        • Hopital 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
        • Hopital 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
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 Names:
  • 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 Names:
  • 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

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

Centre Leon Berard

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

Keywords

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.

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