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

Léon Bérard Center

Status and phase: Completed; Phase 2

Conditions: Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Treatments: Drug: Velbe-Bleomycin-Cisplatin; Drug: Vepeside-ifosfamide-Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02104986

TGM 2013-NS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

117 participants in 4 patient groups

3 courses of Velbe-Bleomycin-Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Velbe-Bleomycin-Cisplatin

4 courses of Velbe-Bleomycin-Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Velbe-Bleomycin-Cisplatin

3 courses Vepeside-ifosfamide-Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Vepeside-ifosfamide-Cisplatin

4 courses Vepeside-ifosfamide-Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Vepeside-ifosfamide-Cisplatin