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

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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.