Document Detail


Interim analysis of the Stockholm III trial of preoperative radiotherapy regimens for rectal cancer.
MedLine Citation:
PMID:  20155787     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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).
Authors:
D Pettersson; B Cedermark; T Holm; C Radu; L P?hlman; B Glimelius; A Martling
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The British journal of surgery     Volume:  97     ISSN:  1365-2168     ISO Abbreviation:  Br J Surg     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-03-10     Completed Date:  2010-03-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372553     Medline TA:  Br J Surg     Country:  England    
Other Details:
Languages:  eng     Pagination:  580-7     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Affiliation:
Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00904813
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Combined Modality Therapy
Feasibility Studies
Female
Follow-Up Studies
Humans
Male
Middle Aged
Postoperative Complications / etiology*
Preoperative Care / methods*
Rectal Neoplasms / radiotherapy*,  surgery
Reoperation
Time Factors
Treatment Outcome

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