Paclitaxel-Bleomycin/Etoposide/Cisplatin vs BEP in poor-prognosis NSGCT with unfavorable tumor marker decline

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial comparing a modified first-line regimen (T-BEP) to standard BEP in adults with metastatic, poor-prognosis NSGCT. After one cycle of BEP, patients with unfavorable tumor marker decline are randomized to receive three additional BEP cycles or three additional cycles of T-BEP (paclitaxel, bleomycin, etoposide, cisplatin) with growth factor support. Screening includes tumor markers, imaging, labs, and CNS assessment as indicated. The study uses a centralized tumor marker decline calculator to guide randomization and aims to determine if T-BEP improves outcomes and tolerability in this high-risk group.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Edgar Israelyan, PhD
• Email: e.israelyan@yandex.ru
• Phone: +7-919-879-92-54

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.