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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
Sponsor: Blokhin's Russian Cancer Research Center
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.
Official title: Paclitaxel+BEP (T-BEP) vs BEP in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
Key Details
Gender
MALE
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-01
Completion Date
2029-10
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Paclitaxel
Paclitaxel 175 mg/m\^2 IV infusion, Day 1, Q3W for 3 cycles in first line
Bleomycin
Bleomycin sulfate 30 mg IV infusion, Days 1,3,5, Q3W for 4 cycles in first line
Etoposide
Etoposide 100 mg/m\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line
Cisplatin
Cisplatin 20 mg/m\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line
G-CSF (Filgrastim)
G-CSF 5 mcg/kg subcutaneous, on Day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9, Q3W for 4 cycles in first line
Locations (1)
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia