A single group trial evaluating one cycle of adjuvant bleomycin, etoposide, cisplatin (BEP) chemotherapy in high risk, stage one non-seminomatous germ cell tumours of the testis (NSGCTT)

Institute of Cancer Research (UK)0 个研究点目标入组 246 人开始时间: 2009年5月14日最近更新: 2020年5月11日

适应症

试验速览

•1. Histologically proven non-seminomatous germ cell tumour (GCT) or mixed GCT (MGCT) of the testis
•2. Histological proven vascular invasion of the primary tumour into the testicular veins or lymphatics
•3. Clinical stage I patients (normal alpha-fetoprotein [AFP] and human chorionic gonadotropin [HCG], or optimum marker decline approaching normal levels after orchidectomy, no evidence of metastases on computed tomography [CT] of the chest, abdomen and pelvis)
•4. Men aged greater than or equal to 16 years
•5. Creatinine clearance greater than 50 ml/min
•6. No previous chemotherapy
•7. White blood cells (WBC) greater than 1.5 x 10^9/l and platelets greater than 100 x 10^9/l
•8. Fit to receive chemotherapy
•9. Able to start BEP chemotherapy as part of 111 study within 6 weeks* of orchidectomy
•10. Written informed consent
•*It is strongly recommended based on previous studies that adjuvant chemotherapy should start within 6 weeks of orchidectomy. However, if there are unavoidable delays this timescale can be extended to 8 weeks.

•1. All patients with seminoma
•2. All patients with non-seminoma greater than clinical stage 1
•3. All patients with no vascular invasion
•4. Previous chemotherapy
•5. Patients with second malignancy except contralateral testicular intraepithelial neoplasia (TIN) and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more then 3 years
•6. Co-morbidity precluding the safe administration of BEP chemotherapy
•7. Patients with renal function impairment (creatinine clearance less than or equal to 50 ml/min)
•8. Patients with liver function impairment (bilirubin greater than 1.25 x upper limit of normal [ULN] and/or aspartate aminotransferase [AST] greater than 2 x ULN)
•9. Patients with pre-existing neuropathy
•10. Patients with pulmonary fibrosis
•11. Patients with serious illness or medical conditions incompatible with the protocol

发起方

Institute of Cancer Research (UK)