A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
Who is this study for? Children and adolescents with extra cranial non seminomateous malignant germ cell tumor
Status: Completed
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• 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 .
Locations
Other Locations
France
CHU
Amiens
CHU
Angers
CHRU
Besançon
CHU
Bordeaux
Chu Morvan
Brest
CHU
Caen
Chu Estaing
Clermont-ferrand
CHU
Dijon
Centre Oscar Lambret
Lille
CHU
Limoges
Hopital de La Timone
Marseille
CHU
Montpellier
CHU
Nancy
CHU
Nantes
CHU
Nice
Hopital Trousseau
Paris
Institut Curie
Paris
CHU
Poitiers
CHU
Reims
CHU
Rennes
CHU
Rouen
Hopital Felix Guyon
Saint Denis
CHRU
Saint Etienne
CHRU
Strasbourg
CHU
Toulouse
CHRU
Tours
Institut Gustave Roussy
Villejuif
Time Frame
Start Date: 2014-05-12
Completion Date: 2021-10-14
Participants
Target number of participants: 117
Treatments
Experimental: 3 courses of Velbe-Bleomycin-Cisplatin
3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Experimental: 4 courses of Velbe-Bleomycin-Cisplatin
4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Experimental: 3 courses Vepeside-ifosfamide-Cisplatin
3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Experimental: 4 courses Vepeside-ifosfamide-Cisplatin
4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses
Authors
HELENE SUDOUR, Eric DORE, Véronique LAITHIER, Cécile VERITE, CHRISTOPHE PIGUET, SYLVIE FASOLA, Isabelle PELLIER, ANGELIQUE ROME, Odile MINCKES, PASCAL CHASTAGNER, FREDERIC MILLOT, ESTELLE THEBAUD, NICOLAS KALFA, PATRICK LUTZ, DANIEL ORBACH, GERARD COUILLAULT, MARTINE MUNZER, VERONIQUE MINARD, MARILYNE POIREE, VIRGINIE GANDEMER
Sponsors
Leads: Centre Leon Berard