Non-seminomatous germ-cell tumors (including testis, retroperitoneal and mediastinal primaries) with a disseminated disease (clinical stages II or III according to AJCC 8th edition) and classified as poor prognosis according to IGCCCG criteria.
Conditions
Brief summary
The primary evaluation criterion of the study is progression-free survival (PFS). PFS will be determined from the first day of the first cycle of BEP to the date of progression or death due to any cause, whichever occurs first. Progression will be defined as: - an increase in tumor markers (...), or - a radiographic progression (...)
Detailed description
Efficacy: - Response criteria Best tumor response will be assessed at the end of treatment (after chemotherapy or after surgery of residual masses, if any) (...); - Overall survival (OS) (...), Tolerance: Toxicity: All toxicities will be evaluated and recorded based on the NCI common toxicity criteria (CTCAE v5.0). They will be described by frequency and grade, by cycle and over all cycles, with the maximum grade over all cycles used as the summary measure for each patient. (...) Treatment-related mortality: (...), Quality of life – Patient-related outcomes: The following questionnaires will be used: QLQ-C30, QLQ-TC26, FACT-GOG-NTX and IPQ, Specific endpoints for the diagnostic study assessing the addition of an early systematic brain MRI: - The proportion of initially brain metastases-free patients who are diagnosed with brain metastases early on a systematic brain MRI performed at the middle of the therapeutic strategy. This proportion will be calculated with its exact 95% confidence interval (...) - The survival after brain metastases relapse
Interventions
DRUGETOPOSIDE ACCORD 20 mg/mL
DRUGsolution à diluer pour perfusion
DRUGBLEOMYCINE BELLON 15 MG
DRUGPOUDRE POUR SOLUTION INJECTABLE
DRUGCISPLATINE KABI 1 mg/ml
DRUGHOLOXAN 1000 mg
DRUGpoudre pour solution injectable
DRUGGRANOCYTE 13 Millions UI/ml
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
Male
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary evaluation criterion of the study is progression-free survival (PFS). PFS will be determined from the first day of the first cycle of BEP to the date of progression or death due to any cause, whichever occurs first. Progression will be defined as: - an increase in tumor markers (...), or - a radiographic progression (...) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: - Response criteria Best tumor response will be assessed at the end of treatment (after chemotherapy or after surgery of residual masses, if any) (...); - Overall survival (OS) (...), Tolerance: Toxicity: All toxicities will be evaluated and recorded based on the NCI common toxicity criteria (CTCAE v5.0). They will be described by frequency and grade, by cycle and over all cycles, with the maximum grade over all cycles used as the summary measure for each patient. (...) Treatment-related mortality: (...), Quality of life – Patient-related outcomes: The following questionnaires will be used: QLQ-C30, QLQ-TC26, FACT-GOG-NTX and IPQ, Specific endpoints for the diagnostic study assessing the addition of an early systematic brain MRI: - The proportion of initially brain metastases-free patients who are diagnosed with brain metastases early on a systematic brain MRI performed at the middle of the therapeutic strategy. This proportion will be calculated with its exact 95% confidence | — |
Countries
France
Outcome results
None listed