• Lancet · Jun 2002

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial.

    • Brian O'Sullivan, Aileen M Davis, Robert Turcotte, Robert Bell, Charles Catton, Pierre Chabot, Jay Wunder, Rita Kandel, Karen Goddard, Anna Sadura, Joseph Pater, and Benny Zee.
    • Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Ontario, Canada. brian.osullivan@rmp.uhn.on.ca
    • Lancet. 2002 Jun 29; 359 (9325): 2235-41.

    BackgroundExternal-beam radiotherapy (delivered either preoperatively or postoperatively) is frequently used in local management of sarcomas in the soft tissue of limbs, but the two approaches differ substantially in their potential toxic effects. We aimed to determine whether the timing of external-beam radiotherapy affected the number of wound healing complications in soft-tissue sarcoma in the limbs of adults.MethodsAfter stratification by tumour size (< or = 10 cm or >10 cm), we randomly allocated 94 patients to preoperative radiotherapy (50 Gy in 25 fractions) and 96 to postoperative radiotherapy (66 Gy in 33 fractions). The primary endpoint was rate of wound complications within 120 days of surgery. Analyses were per protocol for primary outcomes and by intention to treat for secondary outcomes.FindingsMedian follow-up was 3.3 years (range 0.27-5.6). Four patients, all in the preoperative group, did not undergo protocol surgery and were not evaluable for the primary outcome. Of those patients who were eligible and evaluable, wound complications were recorded in 31 (35%) of 88 in the preoperative group and 16 (17%) of 94 in the postoperative group (difference 18% [95% CI 5-30], p=0.01). Tumour size and anatomical site were also significant risk factors in multivariate analysis. Overall survival was slightly better in patients who had preoperative radiotherapy than in those who had postoperative treatment (p=0.0481).InterpretationBecause preoperative radiotherapy is associated with a greater risk of wound complications than postoperative radiotherapy, the choice of regimen for patients with soft-tissue sarcoma should take into account the timing of surgery and radiotherapy, and the size and anatomical site of the tumour.

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