Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): a randomised controlled multicentre trial

niversity Hospital Heidelberg0 个研究点目标入组 392 人开始时间: 2011年2月18日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Newly diagnosed, histologically confirmed colon cancer and/or high rectal cancer
•2. Synchronous metastases not amenable for curative therapy; assessment by a local tumour board at each trial centre consisting of a surgeon, a medical oncologist or gastroenterologist and a radiologist
•3. Resectable primary tumour
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
•5. Adequate medical condition to tolerate surgery and/or chemotherapy
•6. Age greater than or equal to 18 years
•7. Given informed consent

•1. Rectal cancer (tumor up to 12 cm from the anal verge)
•2. Tumour-related symptoms requiring urgent surgery
•3. Patients not eligible for surgery (American Society of Anaesthesiologists [ASA] greater than or equal to IV)
•4. Unequivocal extensive peritoneal metastases, i.e., lower gastrointestinal bleeding requiring transfusion, bowel obstruction, tumour perforation or intractable pain at site of primary tumour
•5. Chemotherapy or radiotherapy during the past 6 months
•6. History of another primary cancer. Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer or other primary solid tumour curatively treated with no known active disease present and no treatment administered for greater than or equal to 5 years prior to randomisation.
•7. Expected lack of compliance

发起方

niversity Hospital Heidelberg