Testing Paclitaxel Added to Chemotherapy for Advanced Germ Cell Tumors
Tests adding paclitaxel to standard chemotherapy in people with advanced germ cell tumors.
Plain-language title generated from the registry record
Registry title: Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline
Key facts
- Where
- Moscow, RussiaSee the site
- Phase
- Phase 2
Where in Russia
- N.N.Blokhin National Medical Research Center of OncologyMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Blokhin's Russian Cancer Research Center
- Trial code
- NCT07847190
- Record updated
- 26 October 2026
- Original 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.Read full original descriptionShow less
Paclitaxel+BEP (T-BEP) vs BEP in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
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.
Inclusion: 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: Patients infected by the Human Immunodeficiency Virus (HIV); Patients with contraindications to taxane agents (hypersensitivity to paclitaxel); Patients with normal range of serum tumor markers before starting treatment; Primary intracranial germ-cell tumors; Patients with seminomas or dysgerminomas; Patients with favorable tumor markers decline; Patients who do not fit inclusion criteria.