Interim analysis of the Stockholm III trial of preoperative radiotherapy regimens for rectal cancer

BACKGROUND: To address issues regarding the fractionation of radiotherapy (RT) and timing of surgery for rectal cancer, a multicentre trial has randomized patients to preoperative short-course RT with two different intervals to surgery, or long-course RT with delayed surgery. The present interim analysis assessed feasibility, compliance and complications after RT and surgery. METHODS: Some 303 patients were randomized to either short-course RT (5 x 5 Gy) and surgery within 1 week (group 1), short-course RT and surgery after 4-8 weeks (group 2) or long-course RT (25 x 2 Gy) and surgery after 4-8 weeks (group 3). RESULTS: Demographic data were similar between groups and there were few protocol violations (5.0-6 per cent). Eight patients (2.6 per cent) developed radiation-induced acute toxicity. There were no significant differences in postoperative complications between groups (46.6, 40.0 and 32 per cent in groups 1, 2 and 3 respectively; P = 0.164). Patients receiving short-course RT with surgery 11-17 days after the start of RT had the highest complication rate (24 of 37). CONCLUSION: Compliance was acceptable and severe acute toxicity was low, irrespective of fractionation. Short-course RT with immediate surgery had a tendency towards more postoperative complications, but only if surgery was delayed beyond 10 days after the start of RT. Registration number: NCT00904813 (http://www.clinicaltrials.gov).

Cedermark, B. (author)
Holm, T.Karolinska Institutet (author)
Radu, CalinUppsala universitet,Enheten för onkologi (author)
Påhlman, LarsUppsala universitet,Kolorektalkirurgi(Swepub:uu)larspahl (author)
Glimelius, BengtKarolinska Institutet,Uppsala universitet,Enheten för onkologi(Swepub:uu)bengglim (author)
Martling, AnnaKarolinska Institutet (author)
Karolinska InstitutetEnheten för onkologi (creator_code:org_t)

In:British Journal of Surgery: Oxford University Press (OUP)97:4, s. 580-5870007-13231365-2168

By the author/editor: Pettersson, D.; Cedermark, B.; Holm, T.; Radu, Calin; Påhlman, Lars; Glimelius, Bengt; show more...; Martling, Anna; show less...

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