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临床试验/DRKS00003855
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

发起方
Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)

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