early Surgery Alone In LOw Rectal cancer (SAILOR)
Research type
Research Study
Full title
Multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer (SAILOR)
IRAS ID
168563
Contact name
Anne-Claire Owen
Contact email
Sponsor organisation
Swansea Bay University Health Board
Eudract number
2014-001373-13
ISRCTN Number
ISRCTN02406823
Research summary
Research Summary
Problem addressed, background and strategic significance
There are 14,000 newly diagnosed rectal cancers in the UK each year and 40 per cent of these are locally advanced. Current guidelines suggest that most locally advanced rectal cancers should receive radiotherapy, often combined with chemotherapy, before surgery to reduce the risk of relapse. There are, however, downsides to radiotherapy which include early and late side effects (bowel, bladder and sexual problems) and surgical complications. Surgical technique and tumour imaging have improved greatly so that good cancer outcomes are being reported in patients who do not receive radiotherapy.
a) Method(s) used
This trial will examine the feasibility of a full trial comparing early surgery alone with the current standard treatment. The intervention to be studied is a modern high quality rectal cancer operation to remove the rectum and anus with formation of a permanent colostomy. Only patients with intermediate stage cancer that can be fully removed by surgery alone will be eligible. The control group will have the current standard treatment, namely preoperative radio(chemo)therapy for 5 weeks followed by the same high quality operation. We will test the acceptability of the intervention (early surgery alone) and test data collection and study processes in preparation for the full trial. Quality assurance and patient safety will be closely monitored by independent committees.
b) Hoped for results of this research
This feasibility study will help plan a definitive trial and, taken together, will clarify which patients should receive preoperative radiotherapy and equally in which patients it can be safely omitted.
c) Changes to the current position if the research is successful
This research will potentially change guidelines for preoperative radiotherapy.Summary of Results
Problem addressed, background and strategic significance There are 14,000 newly diagnosed rectal cancers in the UK each year and 40 per cent of these are locally advanced. Current guidelines suggest that most locally advanced rectal cancers should receive both radiotherapy and chemotherapy before surgery to reduce the risk of relapse. There are, however, downsides to radiotherapy which include early and late side effects (bowel, bladder and sexual problems) and surgical complications. Surgical technique and tumour imaging have improved greatly so that good cancer outcomes are being reported in patients who do not receive radiotherapy.
Method
This study recruited and randomised two groups of patients with intermediate stage rectal cancer. One received chemoradiotherapy followed by surgery, and the other will had surgery alone. Cancer outcomes and quality of life was studied in a rigorous manner with ongoing independent safety analysis. Recruitment methods to maximise willingness to join the trial were used. Reasons for not wishing to take part in the trial were explored through patient interview.
Results of this research
Seven recruitment sites were active across the UK. 51 participants were screened for inclusion, 12 were deemed eligible for study inclusion but only 2 proceeded to randomisation and study participation (one per group). Te main reason for lack of recruitment was patient preference for surgery alone if radiotherapy wasn't absolutely indicated. The number of participants was too small to draw conclusions, and the progression criteria to a full study weren't met. Sites were interviewed about study design and conduct. It was agreed that since the study commenced there was a vogue towards standard treatment being surgery alone. Inclusion criteria were considered too narrow, and difficulties in arranging joint consultation with oncologist and surgeon present. Lack of academic research time and lack of research nurse support was also cited as reasons. Sites considered that the research question remained valid.REC name
Wales REC 6
REC reference
15/WA/0440
Date of REC Opinion
16 Dec 2015
REC opinion
Favourable Opinion