At a glance
ClinicalIndex Comparison Record- ✓Age 11-50 years at randomization
- ✓Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma)
- ✓Exceptionally raised tumor markers can substitute for histologic confirmation in urgent cases
- ✓Primary tumor location: testis, ovary, retroperitoneum, or mediastinum
- ✕Other active primary malignancy (exceptions: adequately treated non-melanomatous skin cancer, germ cell tumor, or malignancy treated ≥5 years ago with no recurrence)
- ✕Prior chemotherapy or radiotherapy, with specific exceptions
- ✕Significant cardiac disease preventing IV fluid hydration for cisplatin
- ✕Significant respiratory disease contraindicating bleomycin use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
In Brief
A Phase 3 clinical trial evaluating Bleomycin (active name: Bleomycin Sulfate), Etoposide, and 3 other interventions for Germ Cell Tumor. Currently recruiting, targeting 500 participants across 28 sites in 3 countries.
Signals
Detailed Summary
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
Study Details
Timeline
Interventions
Standard Arm: Bleomycin 30,000 international units IV weekly for 3 doses (eg. days 1, 8 and 15 or days 2, 9 and 16 of a 21-day cycle) for 4 cycles. Accelerated Arm: Bleomycin 30,000 international units IV weekly for 2 doses (eg. days 1 and 8 or days 2 and 9 of a 14-day cycle) for 4 cycles. Followed by Bleomycin 30,000 international units IV weekly for 4 doses.
Standard Arm: Etoposide 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles. Accelerated Arm: 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles.
Standard Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles. Accelerated Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles.
Standard Arm: 6 mg SCI on day 6 of a 21-day cycle for 4 cycles. Accelerated Arm: 6 mg SCI on day 6 of a 14-day cycle for 4 cycles.
Standard Arm: 10 mcg/kg/day on day6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9/L, of a 21-day cycle for 4 cycles. Accelerated Arm: 10 mcg/kg/day on day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9/L, of a 14-day cycle for 4 cycles.