A phase I trial of preoperative radiation, proctectomy, and endoanal reconstruction

The purpose of this study was to explore the feasibility of sphincter preservation in abdominoperineal resection candidates by combining high-dose preoperative radiation therapy with restorative proctectomy through an endoanal anastomosis. Radiation to the pelvis was given using a three- or four-field technique to 4680 cGy (180 cGy/d) with portals from the top of S1 to 2 cm below the anus. The tumor bed received an additional 360-cGy boost. Four to 6 weeks after radiation therapy was completed, the patients underwent radical surgery. Phase I results for 14 patients are presented. All surgical specimens had negative distal and lateral margins. Surgical complications included one small-bowel obstruction requiring reoperation at 3 weeks, one pulmonary embolism, and one partial disruption (30% of the circumference) of the anastomosis. Bowel control and function were excellent in 8 and good in 4 patients. Function was not yet assessable in the remaining 2 patients.