Clinical trial · Interventional
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
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
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF (Filgrastim) | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- T-BEP
- description
- Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
- interventionNames
- Drug: Paclitaxel
- Drug: Bleomycin
- Drug: Etoposide
- Drug: Cisplatin
- Drug: G-CSF (Filgrastim)
- type
- ACTIVE_COMPARATOR
- label
- BEP
- description
- Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.
- interventionNames
- Drug: Bleomycin
- Drug: Etoposide
- Drug: Cisplatin
- Drug: G-CSF (Filgrastim)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available