Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours (111)

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