A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

• ClinicalTrials.gov Identifier: NCT02104986
• Recruitment Status: Recruiting
• First Posted: April 7, 2014
• Last Update Posted: June 17, 2019
• Sponsor: Centre Leon Berard
• Information provided by (Responsible Party): Centre Leon Berard

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.

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

• 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
• Actual Study Start Date: May 12, 2014
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: May 2024

Arms and Interventions

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

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

• 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

Contacts

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

Locations

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

• Principal Investigator: Cécile CONTER, MD; Centre Léon Bérard, Lyon, FRANCE

More Information

• Responsible Party: Centre Leon Berard
• ClinicalTrials.gov Identifier: NCT02104986 History of Changes
• Other Study ID Numbers: TGM 2013-NS
• First Posted: April 7, 2014
• Last Update Posted: June 17, 2019
• Last Verified: June 2019

Keywords provided by Centre Leon Berard:

non seminomateous malignant germ cell tumour (NSMGCT); Dose De-escalation; Chemotherapy

Additional relevant MeSH terms:

Neoplasms, Germ Cell and Embryonal; Neoplasms; Neoplasms by Histologic Type; 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