A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design.
A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design.
复制标题
DOI：
10.1186/1471-2407-13-417
复制
发表时间：
2013-09-12
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：
Lefevre JH;Rousseau A;Svrcek M;Parc Y;Simon T;Tiret E;French Research Group of Rectal Cancer Surgery (GRECCAR)
新辅助放化疗(RCT)现在是中下段直肠癌的一部分。在目前的临床实践中，如果病变分类为T3/T4或N+，建议在手术切除前进行。组织学完全反应，即手术标本病理检查后无持续性肿瘤细胞侵袭和淋巴结转移(YpT0N0)，已被证明是总体生存和无病生存的独立预后因素。手术切除通常在CRT完成后6至8周内进行，病理完全缓解率约为12%。在回顾性研究中，RCT后间隔时间延长超过10周是增加病理完全缓解率(26%~31%)的独立因素，无病生存期更长，且不增加手术并发症。本研究旨在通过延长直肠癌根治术后至手术的时间，评价264例直肠癌根治术后病理完全缓解率。目前的研究是一项多中心随机试验，在两个平行组中比较了直肠肿瘤RCT结束和癌症手术之间7周和11周的延迟。在RCT结束时，手术被平面化，并在患者书面同意参与后进行随机化。组织学完全反应(YpT0N0)将通过分析完全残留的肿瘤并由包涵组中的两名盲人病理学家双重阅读来确定。手术后，患者将在诊所接受为期5年的随访。参与这项试验不会改变患者在治疗、调查或探视方面的管理。次要终点将包括总存活率和无病存活率、括约肌保存率和直肠系膜切除质量。需要的病人数量是264人。ClinicalTrial.gov：NCT01648894
Neoadjuvant radiochemotherapy (RCT) is now part of the armamentarium of cancer of the lower and middle rectum. It is recommended in current clinical practice prior to surgical excision if the lesion is classified T3/T4 or N+. Histological complete response, defined by the absence of persistent tumor cell invasion and lymph node (ypT0N0) after pathological examination of surgical specimen has been shown to be an independent prognostic factor of overall survival and disease-free survival. Surgical excision is usually performed between 6 and 8 weeks after completion of CRT and pathological complete response rate ranges around 12%. In retrospective studies, a lengthening of the interval after RCT beyond 10 weeks was found as an independent factor increasing the rate of pathological complete response (between 26% and 31%), with a longer disease-free survival and without increasing the operative morbidity. The aim of the present study is to evaluate in 264 patients the rate of pathological complete response rate of rectal cancer after RCT by lengthening the time between RCT and surgery. The current study is a multicenter randomized trial in two parallel groups comparing 7 and 11 weeks of delay between the end of RCT and cancer surgery of rectal tumors. At the end of the RCT, surgery is planified and randomization is performed after patient’s written consent for participation. The histological complete response (ypT0N0) will be determined with analysis of the complete residual tumor and double reading by two pathologists blinded of the group of inclusion. Patients will be followed in clinics for 5 years after surgery. Participation in this trial does not change patient’s management in terms of treatment, investigations or visits. Secondary endpoints will include overall and disease free survival, rate of sphincter conservation and quality of mesorectal excision. The number of patients needed is 264. ClinicalTrial.gov: NCT01648894
登录
查看更多内容
影响因子：
3.7
作者：
de Campos-Lobato, Luiz Felipe;Stocchi, Luca;Kalady, Matthew F.
通讯作者：
Kalady, Matthew F.
影响因子：
158.5
作者：
Kapiteijn, E;Marijnen, CAM;van de Velde, CJH
通讯作者：
van de Velde, CJH
影响因子：
9
作者：
Kim, Nam Kyu;Baik, Seung Hyuk;Cho, Chang Hwan
通讯作者：
Cho, Chang Hwan
影响因子：
3.9
作者：
Moore, HG;Gittleman, AE;Guillem, JG
通讯作者：
Guillem, JG
影响因子：
45.3
作者：
Gerard, Jean-Pierre;Conroy, Thierry;Bedenne, Laurent
通讯作者：
Bedenne, Laurent