STAR-TReC
Research type
Research Study
Full title
Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?
IRAS ID
173279
Contact name
Simon Bach
Contact email
Sponsor organisation
The University of Birmingham
Eudract number
2016-000862-49
ISRCTN Number
ISRCTN14240288
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
STAR-TREC is an international, multi-centre, randomised, phase II feasibility study comprising a 1:1:1 randomisation for eligible subjects with a small, clinically localised rectal cancer between; (a) conventional TME surgery, (b) organ saving utilising chemo radiation and (c) organ saving utilising short course preoperative radiotherapy
The aim of the STAR-TREC study is to find the best way of treating a small rectal cancer. STAR-TREC will compare three different approaches. The “gold standard” treatment involves a large operation (called radical surgery) to remove the whole rectum. Two new approaches are designed to avoid the need for major surgery, we call these the “organ saving” treatments. These organ saving treatments use different types of radiotherapy to try and shrink the cancer as much as possible. How much the cancer shrinks will guide what happens next. In some patients the cancer disappears completely after radiotherapy and no further treatment is needed. In others a small lump remains after radiotherapy, and this is then removed by ‘keyhole’ surgery through the anus. Only the part of bowel wall affected by cancer is removed, most of the rectum and the anus are left alone. Finally, if the cancer does not shrink sufficiently we recommend that the patient has radical surgery to remove the rectum.
While we believe that these new approaches are likely to have fewer side effects than the “gold standard” treatment, not many patients have received organ saving treatment, so we do not know if it will be as effective at curing cancer. In addition, some patients may have organ saving treatment and still need major surgery at some point.
We will learn more about the new organ saving treatments such as how often treatment successfully saves the rectum, what side effects occur and how patients feel after treatment; particularly how well their bowels work.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0186
Date of REC Opinion
23 Sep 2016
REC opinion
Further Information Favourable Opinion