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Background  The Stockholm  III  Trial randomized patients with primary operable rectal cancers to either short‐course radiotherapy ( RT ) with immediate surgery ( SRT ), short‐course  RT  with surgery delayed 4–8 weeks ( SRT ‐delay) or long‐course  RT  with surgery delayed 4–8 weeks. This preplanned interim analysis examined the pathological outcome of delaying surgery.    Methods  Patients randomized to the  SRT  and  SRT ‐delay arms in the Stockholm  III  Trial between October 1998 and November 2010 were included, and data were collected in a prospective register. Additional data regarding tumour regression grade, according to Dworak, and circumferential margin were obtained by reassessment of histopathological slides.    Results  A total of 462 of 545 randomized patients had specimens available for reassessment. Patients randomized to  SRT ‐delay had earlier  ypT  categories, and a higher rate of pathological complete responses (11·8  versus  1·7 per cent;  P  = 0·001) and Dworak grade 4 tumour regression (10·1  versus  1·7 per cent;  P  &lt; 0·001) than patients randomized to  SRT  without delay. Positive circumferential resection margins were uncommon (6·3 per cent) and rates did not differ between the two treatment arms.    Conclusion  Short‐course  RT  induces tumour downstaging if surgery is performed after an interval of 4–8 weeks.

Tumour regression in the randomized Stockholm III Trial of radiotherapy regimens for rectal cancer