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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 35
- 主要终点
- Recurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
One cycle adjuvant BEP(500)
Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15
干预措施: BEP(500) (Drug)
结局指标
主要结局
Recurrence
时间窗: 2 years
To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%
次要结局
- Immediate and delayed toxicity including long-term permanent infertility (>2 years)(0 - > 2 years)
- Relapse free survival(Patients followed up for 5 years)
- Overall survival(Patients followed up for 5 years)