Therapy of c/UICC stage II/III rectal cancer of the upper third by quality controlled total-versus partial mesorectal excision, followed by adjuvant chemotherapy

通过质量控制的全直肠系膜切除术与部分直肠系膜切除术治疗 c/UICC II/III 期上三分之一直肠癌，然后进行辅助化疗

• 批准号: 56296710
• 负责人: Professor Dr. Torsten Liersch, since 4/2012
• 金额: --
• 依托单位: Klinik für Allgemein-, Viszeral- und Kinderchirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2008
• 资助国家: 德国
• 起止时间: 2007-12-31 至 2010-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/56296710?language=en
• 关键词: Therapy; UICC; stage; II; III

The multicentric GAST-05 study aims at identifying the optimal surgical treatment of locally advanced (cUICC stage II/III) rectal cancer located 12-16 cm above the anocutaneous verge. Two established surgical techniques are compared: Total mesorectal excision (TME), to completely eliminate affected and surrounding tissue, bears the risk of post-surgical complications. Partial mesorectal excision (PME) restricts surgery to the afflicted tissue and defined surroundings. PME may be equaly effective in eliminating cancer while limiting post-operative complications. No clinical data have been raised to date that show if TME, or PME, is oncologically superior. To answer this, requires a re-focus on the principles of both resection techniques, including peri- and postoperative quality control. Post-surgical chemotherapy is identical in both trial arms. Primary endpoint is the disease-free survival after 3 years. The GAST-05 study is an add-on study to the ongoing CAO/AIO/ARO-04 trial, which intends to optimise the pre-surgical chemoradiotherapy of cUICC stage II/III cancers in the lower two thirds of the rectum (0-12 cm). The comparison of the long-term outcomes of both studies (GAST-05: surgical procecures; CAO/AIO/ARO-04: intensified preoperative treatment) will influence future studies: They will apply that surgical procedure, which is identified as being superior during the GAST-05 study. Additional gene expression analyses on pre-therapeutically taken tumor probes will show if gene profiling can help to predict individual prognosis.

多中心GAST-05研究旨在确定位于肛门皮肤边缘上方12-16 cm的局部晚期（cUICC II/III期）直肠癌的最佳手术治疗。比较两种已建立的手术技术：全直肠系膜切除术（TME），以完全消除受影响的和周围的组织，承担手术后并发症的风险。部分直肠系膜切除术（PME）将手术限制在受累组织和限定的环境中。PME在消除癌症方面可能同样有效，同时限制术后并发症。到目前为止，还没有临床数据表明TME或PME在肿瘤学上是否具有上级优势。要回答这个问题，需要重新关注两种切除技术的原则，包括术中和术后质量控制。两个试验组的术后化疗相同。主要终点是3年后的无病生存率。GAST-05研究是正在进行的CAO/AIO/ARO-04试验的附加研究，旨在优化直肠下三分之二（0-12 cm）cUICC II/III期癌症的术前放化疗。两项研究的长期结局比较（GAST-05：外科手术; CAO/AIO/ARO-04：强化术前治疗）将影响未来的研究：他们将应用在GAST-05研究中被确定为上级的外科手术。对治疗前肿瘤探针的额外基因表达分析将显示基因谱分析是否有助于预测个体预后。