RECRUITING Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07847190

Registry updated: 2026-09-29

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Description

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.

Interventions

Paclitaxel (Drug)
Paclitaxel 175 mg/m\^2 IV infusion, Day 1, Q3W for 3 cycles in first line
Bleomycin (Drug)
Bleomycin sulfate 30 mg IV infusion, Days 1,3,5, Q3W for 4 cycles in first line
Etoposide (Drug)
Etoposide 100 mg/m\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line
Cisplatin (Drug)
Cisplatin 20 mg/m\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line
G-CSF (Filgrastim) (Drug)
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

Eligibility criteria

Inclusion Criteria: * Age ≥16 years; * Evidence of NSGCT based on histologic examination or clinical evidence (high serum HCG or AFP levels - in case of clinical emergency due to bulky disease, therapy can be started without pathological confirmation of the disease); * Testicular, retroperitoneal, or mediastinal primary site; * Disease classified as poor prognosis according to IGCCCG criteria: * Primary mediastinal NSGCT or * Non-pulmonary visceral metastases or * HCG \> 50,000 UI/l, or AFP \> 10,000 ng/ml, or LDH \> 10 times the upper normal value. * No prior chemotherapy; * No concurrent malignancies which may have an impact of anticipated lifespan (ie, malignancies other than basal-cell skin carcinoma, in situ carcinomas, borderline ovarian tumors etc); * Adequate renal function: measured or calculated glomerular filtration rate \> 60 ml/min. * Absolute baseline granulocyte count ≥0.5\*10\^9, platelets ≥100\*10\^9, bilirubin ≤1.5 ULN. * Unfavorable tumor marker decline after 1st cycle of standard BEP chemotherapy calculated according to time to normalization from the K. Fizazi study in JCO 2004. * Signed informed consent before protocol-specific procedures. Exclusion Criteria: * Primary intracranial germ-cell tumors; * Patients with seminomas or dysgerminomas; * Patients with normal range of serum tumor markers before starting treatment; * Patients with favorable tumor markers decline; * Patients infected by the Human Immunodeficiency Virus (HIV); * Patients with contraindications to taxane agents (hypersensitivity to paclitaxel); * Patients who do not fit inclusion criteria.

Conditions

Germ Cell Cancer Metastatic

Locations

N.N. Blokhin National Medical Research Center of Oncology — Moscow, Russia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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