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

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 testicularveins or lymphatics

• Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approachingnormal 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 oforchidectomy

• Written informed consent *If there are unavoidable delays this timescale can beextended 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 celltumour 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