Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectalbe metastases (UICC stage IV) - A randomised controlled multicentral trial

结肠癌伴同步未切除转移瘤患者的原发肿瘤切除与全身治疗前不切除的对比（UICC IV 期）——一项随机对照多中心试验

• 批准号: 174159064
• 负责人: Professor Dr. Martin A. Schneider, since 9/2019
• 金额: --
• 依托单位: Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2011
• 资助国家: 德国
• 起止时间: 2010-12-31 至 2014-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/174159064?language=en
• 关键词: Resection; primary; tumour; versus; no

The primary therapy for patients with colon cancer and synchronous metastases not amenable for curative therapy is systemic chemotherapy. It has, however, remained uncertain, if patients without symptomatic disease should undergo resection of the primary tumour prior to the beginning of chemotherapy. As colonic resection is associated with a known morbidity of 20-30% and mortality of up to 8% in these patients, indication for surgery in patients without marked symptoms needs to be justified by a relevant benefit in overall survival. Although data on metastatic renal cancer together with the results of the two largest non-randomized studies on patients with metastatic colorectal cancer suggest a potential benefit in overall survival for removal of the primary tumour, a randomised controlled trial in patients with colon cancer has not been performed yet. The SYNCHRONOUS Trial is a randomised controlled multicentre trial to investigate, whether resection of the primary tumour prolongs overall survival of patients with colon cancer and synchronous metastases not amenable for curative therapy. Progressionfree survival, time-to-treatment failure, time-to-development of tumour related local symptoms (control group), morbidity, mortality and quality of life will be assessed as secondary endpoints. Absence of a relevant survival benefit for patients undergoing colonic resection will have direct impact on current clinical practice and may, moreover, help to prevent procedure-related morbidity and mortality.

对于无法根治的结肠癌和同步转移的患者，主要的治疗方法是全身化疗。然而，目前还不确定没有症状性疾病的患者是否应该在化疗开始前切除原发肿瘤。由于在这些患者中，结肠切除与20-30%的已知发病率和高达8%的死亡率有关，因此，对于没有明显症状的患者，手术的适应症需要根据总体存活率的相关好处来证明。虽然关于转移性肾癌的数据以及两项关于转移性结直肠癌患者的最大非随机研究的结果表明，切除原发肿瘤对总体存活率有潜在的好处，但尚未在结肠癌患者中进行随机对照试验。同步试验是一项随机对照多中心试验，旨在调查切除原发肿瘤是否延长了结肠癌和无法根治的同步转移患者的总体生存时间。无进展存活率、治疗时间失败、肿瘤相关局部症状的发展时间(对照组)、发病率、死亡率和生活质量将被评估为次要终点。对于接受结肠切除术的患者来说，缺乏相关的生存益处将直接影响当前的临床实践，而且可能有助于预防与手术相关的发病率和死亡率。