Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 384
- 试验地点
- 6
- 主要终点
- Primary outcomes:
研究概览
简要总结
Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.
详细描述
Prospective, randomized, multi-centre, open phase III study with two parallel groups of patients according to the eligibility criteria. The times in both hierarchical classified endpoints will be measured as times from randomization.
Patients with macroscopic complete resection of colorectal liver metastases will be randomized in:
Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and follow-up
or
Arm B: follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients after R0-resection of colorectal liver metastases
- •age: >= 18 years
- •Karnofsky-Index >= 70%
- •neutrophiles >1,5 x10e9/l, thrombocytes 100 x10e9/l
- •adequate contraception for male and female patients
- •oral and written informed consent (GCP)
排除标准
- •other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)
- •other participation in clinical trials within 30 days before randomization
- •previous chemotherapy (except adjuvant chemotherapy with an interval of >= 6 months)
- •creatinine clearance <50 ml/min
- •hepatic insufficiency (ALAT, ASAT, Bilirubin, AP >5 x upper limit)
- •peripheral neuropathy > CTC grade 1
- •uncontrolled cardiac insufficiency or angina pectoris
- •active infections
- •severe neurological or psychiatric illness
- •breast-feeding or pregnant women
- •incapacity to take part in regular visits
结局指标
主要结局
Primary outcomes:
Disease free survival
次要结局
- Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity