drugset / Trial / NCT07847190
Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
Phase 2
Recruiting
60 enrolled
Blokhin's Russian Cancer Research Center
Moscow Multidisciplinary Clinical Center "Kommunarka" · collabN.N. Petrov National Medical Research Center of Oncology · collabNational Medical Research Radiological Centre of the Ministry of Health of Russia · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
GETUG-13 study has prospectively confirmed poor outcomes in advanced germ cell tumors (GCT) patients with unfavorable decrease of tumor markers after 1 cycle of BEP chemotherapy. There is an unmet medical need to improve outcomes in this subset of patients, however the dose-dense regimen proposed in the above-mentioned trial cannot be implemented in routine clinical practice. T-BEP regimen may have advantage over the traditional BEP regimen as first-line therapy for poor-risk GCT Treatment escalation with T-BEP regimen may be an effective and tolerable therapeutic option for advanced GCT patients with unfavorable tumor markers decline.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2028-10
- Completion
- 2029-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Background | Bleomycin | Unknown | 30 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |