Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours

• Status: Active, not recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Collaborators: Cancer Research UK; University Hospital Birmingham NHS Foundation Trust

Criteria

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