| Objective: |
TREC was a randomised phase II trial to test the feasibility of randomisation between TME and an organ preserving policy of short course pre-operative radiotherapy (SCPRT) delay followed by transanal endoscopic microsurgery (TEM). STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate the patient recruitment attained in the TREC study, to 4 per month in the first year of recruitment and 6 per month in the second. This would demonstrate deliverability of a phase III study. |
| Aim: |
The aim of this study is to assess the feasibility of successfully recruiting to a large, multi-centre randomised trial comparing radical surgery versus organ saving treatment using (chemo)radiotherapy followed by selective transanal microsurgery, to evaluate whether it is possible to accelerate patient recruitment from 2 per month, as attained in the previous TREC study, to 6 per month over a two-year period. |
| Methods: |
STAR-TREC is a randomised, three arm (1:1:1) study using the following arms:
Standard TME surgery (control)
Organ saving using:
long course concurrent chemoradiation
short course radiotherapy For organ-preserving strategies clinical response to radiotherapy determines the next treatment step. Radiotherapy response is evaluated using endoscopy and the tumour regression grade, as assessed by MRI. The first assessment at 11-13 weeks (from radiotherapy start) using MRI and endoscopy will identify a minority of non-responders who should convert to TME surgery. Patients demonstrating a satisfactory radiotherapy response at 11-13 weeks will be reassessed by endoscopy at 16-20 weeks. Re-evaluation determines if the STAR-TREC criteria for complete clinical response (cCR) are met. Patients who achieve cCR may progress directly to active surveillance. Those who do not fulfil the criteria for cCR will progress to excision biopsy with transanal endoscopic microsurgery (TEM).
Patients in the organ saving arm will be assigned to either;
A. Long course concurrent chemoradiation:
Capecitabine: 825 mg/m² orally, b.i.d., on radiotherapy days Radiotherapy: A dose of 50 Gy, applied to the primary tumour and surrounding mesorectum, in 25 fractions of 2 Gy, 5 days a week.
or B. Short course preoperative radiotherapy A dose of 25Gy, applied, to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week.
As a feasibility study, this trial will have recruitment rate as it's primary outcome. |
| Reason for International Trial: |
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