TREC
Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study
N = 55
- Population
- Adults with rectal adenocarcinoma staged T2 or lower, maximum diameter 30 mm or less, no lymph node involvement or metastases
- Design
- Randomised (1:1), open-label feasibility study at 21 tertiary referral centres in the UK; 55 patients were randomly assigned at 15 sites. Patients with rectal adenocarcinoma staged T2 or lower, maximum diameter 30 mm or less, without lymph node involvement or metastases, had organ preservation (short-course radiotherapy, then transanal endoscopic microsurgery after 8 to 10 weeks, with planned early conversion to total mesorectal excision if the specimen showed features associated with a higher risk of local recurrence) or total mesorectal excision. A non-randomised prospective registry captured patients for whom randomisation was considered inappropriate. Primary endpoint: cumulative randomisation at 12, 18 and 24 months. Secondary outcomes covered safety, efficacy and quality of life. Registered as ISRCTN14422743 (no ClinicalTrials.gov number).
- Primary endpoint
- Cumulative randomisation (feasibility)
- Arms
- Organ preservation: short-course radiotherapy then TEM (experimental, n = 27): Short-course radiotherapy (25 Gy in five fractions) followed by transanal endoscopic microsurgery after 8 to 10 weeks, with planned early conversion to total mesorectal excision for high-risk histopathology
- Radical surgery: total mesorectal excision (control, n = 28): Total mesorectal excision
- People
- Bach SP, senior author Sebag-Montefiore D, TREC collaborators
Δ Serious adverse events−24 points
Show the numbers
| Endpoint | Analysis | Organ preservation: short-course radiotherapy then TEM | Radical surgery: total mesorectal excision | Effect |
|---|---|---|---|---|
| Serious adverse eventsPatients randomly assigned: 27 to organ preservation and 28 to total mesorectal excision (intention-to-treat population named for the secondary outcomes)Serious adverse events (secondary outcome of a feasibility study) | primaryBach 2021 | 15% | 39% | P=0.04 (chi-squared test)Four of 27 patients versus 11 of 28. No patients died within 30 days of initial treatment. One patient randomly assigned to organ preservation died within 6 months after conversion to total mesorectal excision with anastomotic leakage. A feasibility study; the comparison was not designed to test efficacy or safety. |
| Organ preservation rate27 patients randomly assigned to organ preservationOrgan preservation achieved in patients randomly assigned to organ preservation (secondary outcome) | primaryBach 2021 | 70% | — | 19 of 27 patients. 8 of 27 (30%) were converted to total mesorectal excision, and 8 of 27 (30%) achieved a complete response to radiotherapy (7 pathological complete responses and 1 clinical complete response without transanal endoscopic microsurgery). Neither the abstract nor the full text gives a time point for this figure, and the full text does not define organ preservation beyond the intervention (short-course radiotherapy followed by local excision); the 8 conversions were 5 planned early conversions after transanal endoscopic microsurgery pathology and 3 protocol deviations (low anterior resection without transanal endoscopic microsurgery). Cancer outcomes are not reported for the randomised comparison; the authors state that larger randomised studies such as STAR-TREC are needed to determine oncological outcomes. |
| Endpoint | Analysis | Organ preservation: short-course radiotherapy then TEM | Radical surgery: total mesorectal excision | Effect |
|---|---|---|---|---|
| Serious adverse eventsPatients randomly assigned: 27 to organ preservation and 28 to total mesorectal excision (intention-to-treat population named for the secondary outcomes)Serious adverse events (secondary outcome of a feasibility study) | primaryBach 2021 | 15% | 39% | P=0.04 (chi-squared test)Four of 27 patients versus 11 of 28. No patients died within 30 days of initial treatment. One patient randomly assigned to organ preservation died within 6 months after conversion to total mesorectal excision with anastomotic leakage. A feasibility study; the comparison was not designed to test efficacy or safety. |
| Organ preservation rate27 patients randomly assigned to organ preservationOrgan preservation achieved in patients randomly assigned to organ preservation (secondary outcome) | primaryBach 2021 | 70% | — | 19 of 27 patients. 8 of 27 (30%) were converted to total mesorectal excision, and 8 of 27 (30%) achieved a complete response to radiotherapy (7 pathological complete responses and 1 clinical complete response without transanal endoscopic microsurgery). Neither the abstract nor the full text gives a time point for this figure, and the full text does not define organ preservation beyond the intervention (short-course radiotherapy followed by local excision); the 8 conversions were 5 planned early conversions after transanal endoscopic microsurgery pathology and 3 protocol deviations (low anterior resection without transanal endoscopic microsurgery). Cancer outcomes are not reported for the randomised comparison; the authors state that larger randomised studies such as STAR-TREC are needed to determine oncological outcomes. |
Appears in
Sources
Bach SP, Gilbert A, Brock K, Korsgen S, Geh I, Hill J, et al. Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study. Lancet Gastroenterol Hepatol. 2021;6(2):92-105.