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Original Article
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Volume 345:638-646 August 30, 2001 Number 9
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Preoperative Radiotherapy Combined with Total Mesorectal Excision for Resectable Rectal Cancer
Ellen Kapiteijn, M.D., Corrie A.M. Marijnen, M.D., Iris D. Nagtegaal, M.D., Hein Putter, Ph.D., Willem H. Steup, M.D., Ph.D., Theo Wiggers, M.D., Ph.D., Harm J.T. Rutten, M.D., Ph.D., Lars Pahlman, M.D., Ph.D., Bengt Glimelius, M.D., Ph.D., J. Han J.M. van Krieken, M.D., Ph.D., Jan W.H. Leer, M.D., Ph.D., Cornelis J.H. van de Velde, M.D., Ph.D., for the Dutch Colorectal Cancer Group

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ABSTRACT

Background Short-term preoperative radiotherapy and total mesorectal excision have each been shown to improve local control of disease in patients with resectable rectal cancer. We conducted a multicenter, randomized trial to determine whether the addition of preoperative radiotherapy increases the benefit of total mesorectal excision.

Methods We randomly assigned 1861 patients with resectable rectal cancer either to preoperative radiotherapy (5 Gy on each of five days) followed by total mesorectal excision (924 patients) or to total mesorectal excision alone (937 patients). The trial was conducted with the use of standardization and quality-control measures to ensure the consistency of the radiotherapy, surgery, and pathological techniques.

Results Of the 1861 patients randomly assigned to one of the two treatment groups, 1805 were eligible to participate. The overall rate of survival at two years among the eligible patients was 82.0 percent in the group assigned to both radiotherapy and surgery and 81.8 percent in the group assigned to surgery alone (P=0.84). Among the 1748 patients who underwent a macroscopically complete local resection, the rate of local recurrence at two years was 5.3 percent. The rate of local recurrence at two years was 2.4 percent in the radiotherapy-plus-surgery group and 8.2 percent in the surgery-only group (P<0.001).

Conclusions Short-term preoperative radiotherapy reduces the risk of local recurrence in patients with rectal cancer who undergo a standardized total mesorectal excision.


Source Information

From the Departments of Surgery (E.K., C.J.H.V.), Clinical Oncology (C.A.M.M.), and Medical Statistics (H.P.), Leiden University Medical Center, Leiden; the Departments of Pathology (I.D.N., J.H.J.M.K.) and Radiotherapy (J.W.H.L.), University Medical Center St. Radboud, Nijmegen; the Department of Surgery, Leyenburg Hospital, The Hague (W.H.S.); the Department of Surgery, University Hospital Groningen, Groningen (T.W.); and the Department of Surgery, Catharina Hospital, Eindhoven (H.J.T.R.) — all in the Netherlands; and the Departments of Surgery (L.P.) and Oncology (B.G.), Akademiska Sjukhuset, Uppsala, Sweden.

Address reprint requests to Dr. van de Velde at the Department of Surgery K6-R, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, the Netherlands, or at velde{at}lumc.nl.

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