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

GAST-05多中心研究旨在确定局部进展期(cUICC II/III期)直肠癌的最佳外科治疗方案，该方案位于无皮肤边缘以上12-16厘米。比较了两种公认的手术技术：全直肠系膜切除术(TME)，完全消除受影响的组织和周围组织，承担手术后并发症的风险。直肠系膜部分切除术(PME)将手术局限于受影响的组织和特定的环境。PME在消除癌症的同时限制术后并发症可能同样有效。到目前为止，还没有临床数据表明TME或PME在肿瘤方面是否优越。要回答这个问题，需要重新关注两种切除技术的原则，包括围手术期和术后的质量控制。术后化疗在两个试验组中都是相同的。主要终点是3年后的无病生存。GAST-05研究是正在进行的CAO/AIO/ARO-04试验的补充研究，旨在优化直肠下三分之二(0-12厘米)的CUICC II/III期癌症的术前放化疗。两项研究(GAST-05：手术过程；CAO/AIO/ARO-04：强化术前治疗)的长期结果的比较将影响未来的研究：他们将应用在GAST-05研究中被确定为更好的手术方法。对治疗前服用的肿瘤探针进行的额外基因表达分析将表明，基因图谱是否有助于预测个体预后。

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.