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)
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