DRKS00003855已完成未知
Resection of the primary tumor before Ctx vs. first-line Ctx in metastasized CRC - SYNCHRONOUS
Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)0 个研究点目标入组 41 人开始时间: 2012年12月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 100 Years(—)
- 性别
- All
入选标准
- •1. Newly diagnosed, histologically confirmed colon 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
排除标准
- •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
研究者
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