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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

Primary Purpose

Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Velbe-Bleomycin-Cisplatin
Vepeside-ifosfamide-Cisplatin
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extra Cranial Non Seminomateous Malignant Germ Cell Tumour focused on measuring non seminomateous malignant germ cell tumour (NSMGCT), Dose De-escalation, Chemotherapy

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • CHU
  • CHRU
  • CHU
  • Chu Morvan
  • CHU
  • Chu Estaing
  • CHU
  • Centre Oscar Lambret
  • CHU
  • Hopital de La Timone
  • CHU
  • CHU
  • CHU
  • CHU
  • Institut Curie
  • Hopital Trousseau
  • CHU
  • CHU
  • CHU
  • CHU
  • Hopital Felix Guyon
  • CHRU
  • CHRU
  • CHU
  • CHRU
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

3 courses of Velbe-Bleomycin-Cisplatin

4 courses of Velbe-Bleomycin-Cisplatin

3 courses Vepeside-ifosfamide-Cisplatin

4 courses Vepeside-ifosfamide-Cisplatin

Arm Description

3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses

4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses

3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses

4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
complete remission rate after 1st line treatment (chemotherapy and surgery)

Full Information

First Posted
March 27, 2014
Last Updated
August 26, 2022
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT02104986
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2014 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
Keywords
non seminomateous malignant germ cell tumour (NSMGCT), Dose De-escalation, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 courses of Velbe-Bleomycin-Cisplatin
Arm Type
Experimental
Arm Description
3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Arm Title
4 courses of Velbe-Bleomycin-Cisplatin
Arm Type
Experimental
Arm Description
4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Arm Title
3 courses Vepeside-ifosfamide-Cisplatin
Arm Type
Experimental
Arm Description
3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Arm Title
4 courses Vepeside-ifosfamide-Cisplatin
Arm Type
Experimental
Arm Description
4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Intervention Type
Drug
Intervention Name(s)
Velbe-Bleomycin-Cisplatin
Other Intervention Name(s)
Desescalation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vepeside-ifosfamide-Cisplatin
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
Title
complete remission rate after 1st line treatment (chemotherapy and surgery)
Time Frame
3 weeks after the end of treatment (CT + surgery)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile CONTER, MD
Organizational Affiliation
Centre Léon Bérard, Lyon, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CHRU
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Chu Morvan
City
Brest
ZIP/Postal Code
26609
Country
France
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Chu Estaing
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital de La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CHU
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHU
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Felix Guyon
City
Saint Denis
ZIP/Postal Code
97405
Country
France
Facility Name
CHRU
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CHRU
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHU
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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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