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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 : Recruiting
First Posted : April 7, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 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
Study Start Date : May 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


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



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) ]


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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

Information from the National Library of Medicine

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


Contacts
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Contact: Ellen BLANC ellen.blanc@lyon.unicancer.fr

Locations
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France
CHU Not yet recruiting
Amiens, France, 80054
Principal Investigator: Catherine DEVOLDERE         
CHU Recruiting
Angers, France, 49033
Principal Investigator: Isabelle PELLIER         
CHRU Not yet recruiting
Besançon, France, 25030
Principal Investigator: Véronique LAITHIER         
CHU Recruiting
Bordeaux, France, 33076
Principal Investigator: Cécile VERITE         
Chu Morvan Not yet recruiting
Brest, France, 26609
Principal Investigator: Philippe LEMOINE         
CHU Not yet recruiting
Caen, France, 14033
Principal Investigator: Odile MINCKES         
Chu Estaing Not yet recruiting
Clermont-ferrand, France, 63003
Principal Investigator: Eric DORE         
CHU Not yet recruiting
Dijon, France, 21079
Principal Investigator: GERARD COUILLAULT         
Centre Oscar Lambret Recruiting
Lille, France, 59000
Principal Investigator: HELENE SUDOUR         
CHU Not yet recruiting
Limoges, France, 87042
Principal Investigator: CHRISTOPHE PIGUET         
Hopital de La Timone Recruiting
Marseille, France, 13385
Principal Investigator: ANGELIQUE ROME         
CHU Not yet recruiting
Montpellier, France, 34295
Principal Investigator: NICOLAS KALFA         
CHU Recruiting
Nancy, France, 54511
Principal Investigator: PASCAL CHASTAGNER         
CHU Recruiting
Nantes, France, 44093
Principal Investigator: ESTELLE THEBAUD         
CHU Recruiting
Nice, France, 06202
Principal Investigator: MARILYNE POIREE         
Institut Curie Not yet recruiting
Paris, France, 75005
Principal Investigator: DANIEL ORBACH         
Hopital Trousseau Not yet recruiting
Paris, France, 75012
Principal Investigator: SYLVIE FASOLA         
CHU Not yet recruiting
Poitiers, France, 86021
Principal Investigator: FREDERIC MILLOT         
CHU Not yet recruiting
Reims, France, 51092
Principal Investigator: MARTINE MUNZER         
CHU Not yet recruiting
Rennes, France, 35203
Principal Investigator: VIRGINIE GANDEMER         
CHU Recruiting
Rouen, France, 76031
Principal Investigator: CECILE DUMESNIL DE MARICOURT         
Hopital Felix Guyon Not yet recruiting
Saint Denis, France, 97405
Principal Investigator: MATHILDE JEHANNE         
CHRU Recruiting
Saint Etienne, France, 42055
Principal Investigator: CLAIRE BERGER         
CHRU Not yet recruiting
Strasbourg, France, 67098
Principal Investigator: PATRICK LUTZ         
CHU Not yet recruiting
Toulouse, France, 31059
Principal Investigator: MARIE PIERRE CASTEIX         
CHRU Not yet recruiting
Tours, France, 37044
Principal Investigator: ODILE LEJARS         
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Principal Investigator: VERONIQUE MINARD         
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Cécile CONTER, MD Centre Léon Bérard, Lyon, FRANCE

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02104986     History of Changes
Other Study ID Numbers: TGM 2013-NS
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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 by Histologic Type
Neoplasms
Cisplatin
Ifosfamide
Isophosphamide mustard
Bleomycin
Vinblastine
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators