Clinical trial · Interventional
Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours
A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis (NSGCTT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis. If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.
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 |
|---|---|---|---|
| Stage I Testicular Non-Seminomatous Germ Cell Tumor | Testicular Non-Seminomatous Germ Cell Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEP(500) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One cycle adjuvant BEP(500)
- description
- Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15
- interventionNames
- Drug: BEP(500)
Primary outcomes (1)
- measure
- Recurrence
- timeFrame
- 2 years
- description
- To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%
Secondary outcomes (3)
- measure
- Immediate and delayed toxicity including long-term permanent infertility (>2 years)
- timeFrame
- 0 - > 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven non-seminomatous germ cell tumour of combined GCT (NSGCT + seminoma)of the testis * Histologically proven vascular invasion of the primary tumour into the testicular veins or lymphatics * Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approaching normal levels after orchidectomy AND no evidence of metastases on CT of chest, abdomen and pelvis) * Men aged 16 years or over * Creatinine clearance \> 50 ml/min * No previous chemotherapy * WBC \> 1.5 x 10\^9/l and platelets 100 x 10\^9/l * Fit to receive chemotherapy * Able to start BEP(500) chemotherapy as part of 111 study within 6\* weeks of orchidectomy * Written informed consent \*If there are unavoidable delays this timescale can be extended to 8 weeks Exclusion Criteria: * All patients with pure seminoma * All patients with non-seminoma or combined NSGCT + seminoma \> stage 1 * All patients with no vascular invasion * Previous chemotherapy * Patients with second malignancy except contralateral TIN and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more than 3 years * Co-morbidity precluding the safe administration of BEP(500) chemotherapy * Patients with renal function impairment (bilirubin \>1.25 x ULN and/or AST \>2 x ULN) * Patients with pre-existing neuropathy * Patients with pulmonary fibrosis * Patients with serious illness or medical conditions incompatible with the protocol
References
Publications (1)
- RESULTCullen M, Huddart R, Joffe J, Gardiner D, Maynard L, Hutton P, Mazhar D, Shamash J, Wheater M, White J, Goubar A, Porta N, Witts S, Lewis R, Hall E; 111 Trial Management Group. The 111 Study: A Single-arm, Phase 3 Trial Evaluating One Cycle of Bleomycin, Etoposide, and Cisplatin as Adjuvant Chemotherapy in High-risk, Stage 1 Nonseminomatous or Combined Germ Cell Tumours of the Testis. Eur Urol. 2020 Mar;77(3):344-351. doi: 10.1016/j.eururo.2019.11.022. Epub 2020 Jan 1. PMID 31901440