Cotte Eddy, Villeneuve Laurent, Passot Guillaume, Boschetti Gilles, Bin-Dorel Sylvie, Francois Yves, Glehen Olivier
BMC Cancer. 2015 Feb 12;15:47. doi: 10.1186/s12885-015-1060-0.
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.
METHODS/DESIGN: 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.
大多数患有直肠癌和转移灶的患者由于存在广泛且无法切除的转移性疾病而不适合进行根治性治疗。在这种情况下，原发性肿瘤切除术仍存在争议。直肠手术可治疗或预防症状，并避免与原发性肿瘤相关的急性并发症风险。几项关于结直肠癌的研究似乎在原发性肿瘤切除对生存的影响方面显示出有趣的结果。迄今为止，尚无随机试验甚至前瞻性研究评估原发性肿瘤切除术对无法切除转移灶的结直肠癌患者总生存的影响。所有已发表的研究均为回顾性研究，且涵盖结肠癌和直肠癌。直肠癌与直肠手术相关的特定问题有关。手术更为复杂，与结肠手术相比，可能导致更多的发病率和术后功能障碍（造口、消化、性功能、泌尿功能）。另一方面，直肠肿瘤进展相关的症状通常非常致残：疼痛、直肠综合征。
方法/设计：GRECCAR 8是一项多中心随机开放标签对照试验，旨在评估原发性肿瘤切除术对伴有无法切除同步转移灶的直肠癌患者生存的影响。患者在入组前必须接受至少4个疗程的一线全身化疗。在一线化疗期间出现转移性疾病进展的患者将被排除在研究之外。患者将按1:1的比例随机分配至A组：原发性肿瘤切除术后进行全身化疗与B组：单纯全身化疗。主要终点将是从随机分组日期至死亡日期或随访结束（2年）的总生存。次要终点将包括无进展生存、生活质量、化疗毒性、原发性肿瘤和转移性疾病对化疗的反应、术后发病率和死亡率、不符合术后化疗条件的患者比例（A组）、原发性肿瘤相关并发症和急诊手术率（B组）。所需患者数量为290例。
ClinicalTrial.gov：NCT02314182。
