GRECCAR 8: impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis: a randomized multicentre study.
GRECCAR 8: impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis: a randomized multicentre study.
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DOI：
10.1186/s12885-015-1060-0
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发表时间：
2015-02-12
期刊：
影响因子：
3.8
通讯作者：
French Research Group of Rectal Cancer Surgery (GRECCAR)
中科院分区：
文献类型：
--
作者：
Cotte E;Villeneuve L;Passot G;Boschetti G;Bin-Dorel S;Francois Y;Glehen O;French Research Group of Rectal Cancer Surgery (GRECCAR)
大多数直肠癌和转移的患者由于广泛和不可切除的转移性疾病而不适合根治性治疗。原发性肿瘤切除在这种情况下仍有争议。直肠手术治疗或预防症状，并避免与原发肿瘤相关的急性并发症的风险。一些关于结肠直肠癌的研究似乎显示了一些有趣的结果在生存方面更倾向于切除原发肿瘤。迄今为止，没有随机试验甚至前瞻性研究评估原发肿瘤切除对结直肠癌不可切除转移患者总生存的影响。所有发表的研究都是回顾性的，包括结肠癌和直肠癌。直肠癌与直肠手术相关的特殊问题有关。与绞痛手术相比，手术更为复杂，可能是更多发病率和术后功能障碍（造口、消化、性、尿）的来源。另一方面，与直肠肿瘤进展相关的症状往往是非常致残的：疼痛，直肠综合征。GRECCAR 8是一项多中心随机开放标签对照试验，旨在评估原发肿瘤切除对不可切除同步转移的直肠癌患者生存的影响。患者在纳入前必须接受至少4个疗程的前期全身化疗。在前期化疗期间出现进展性转移性疾病的患者将被排除在研究之外。患者将按1:1的比例随机分配到a组：原发肿瘤切除后全身化疗和B组：单独全身化疗。主要终点将是从随机化日期到死亡日期或到随访结束（2年）的总生存率。次要终点包括无进展生存期、生活质量、化疗毒性、原发肿瘤和转移性疾病对化疗的反应、术后发病率和死亡率、不适合术后化疗的患者比率（A组）、原发肿瘤相关并发症和紧急手术率（B组）。需要的病人人数是290人。ClinicalTrial.gov: NCT02314182
A majority of patients with rectal cancer and metastasis are not eligible to curative treatment because of an extensive and unresectable metastatic disease. Primary tumor resection is still debated in this situation. Rectal surgery treats or prevents the symptoms and avoids the risk of acute complications related to the primary tumor. Several studies on colorectal cancers seem to show interesting results in terms of survival in favor to the resection of the primary tumor. To date, no randomized trial or even a prospective study has assessed the impact of primary tumor resection on overall survival in patients with colorectal cancer with unresectable metastasis. All published studies were retrospective and included colon and rectal cancers. Rectal cancer is associated with specific problems related to the rectal surgery. Surgery is more complex, and may be source of more morbidity and postoperative functional dysfunctions (stoma, digestive, sexual, urinary) than colic surgery. On the other hand, symptoms related to the progression of rectal tumor are often very disabling: pain, rectal syndrome. GRECCAR 8 is a multicentre randomized open-label controlled trial aimed to evaluate the impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis. Patients must undergo upfront systemic chemotherapy for at least 4 courses before inclusion. Patients with progressive metastatic disease during upfront chemotherapy will be excluded from the study. Patients will be randomly assigned in a 1:1 ratio to Arm A: primary tumor resection followed by systemic chemotherapy versus Arm B: systemic chemotherapy alone. Primary endpoint will be overall survival measured from the date of randomization to the date of death or to the end of follow-up (2 years). Secondary endpoints will include progression-free survival, quality of life, toxicity of chemotherapy, response of the primary tumor and metastatic disease to chemotherapy, postoperative morbidity and mortality, rate of patient not eligible for postoperative chemotherapy (arm A), primary tumor related complications and rate of emergency surgery (arm B). The number of patients needed is 290. ClinicalTrial.gov: NCT02314182
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