NCT07847190RecruitingPhase 2
Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline
Paclitaxel+BEP (T-BEP) vs BEP in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 1 Oct 2024
- Primary completion date
- Oct 2028
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Diseases
- Childhood cancers
- NCT number
- NCT07847190
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients infected by the Human Immunodeficiency Virus (HIV);
- Patients with contraindications to taxane agents (hypersensitivity to paclitaxel);
Lab values
- Patients with normal range of serum tumor markers before starting treatment;
Other
- Primary intracranial germ-cell tumors;
- Patients with seminomas or dysgerminomas;
- Patients with favorable tumor markers decline;
- Patients who do not fit inclusion criteria.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| N.N.Blokhin National Medical Research Center of Oncology Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.