Article ; Online: Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC)? Protocol for the international, multicentre, rolling phase II/III partially randomized patient preference trial evaluating long-course concurrent chemoradiotherapy versus short-course radiotherapy organ preservation approaches.
2022 Volume 24, Issue 5, Page(s) 639–651
Abstract: Aim: Organ-saving treatment for early-stage rectal cancer can reduce patient-reported side effects compared to standard total mesorectal excision (TME) and preserve quality of life. An optimal strategy for achieving organ preservation and longer-term ... ...
| Abstract | Aim: Organ-saving treatment for early-stage rectal cancer can reduce patient-reported side effects compared to standard total mesorectal excision (TME) and preserve quality of life. An optimal strategy for achieving organ preservation and longer-term oncological outcomes are unknown; thus there is a need for high quality trials. Method: Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC) is an international three-arm multicentre, partially randomized controlled trial incorporating an external pilot. In phase III, patients with cT1-3b N0 tumours, ≤40 mm in diameter, who prefer organ preservation are randomized 1:1 between mesorectal long-course chemoradiation versus mesorectal short-course radiotherapy, with selective transanal microsurgery. Patients preferring radical surgery receive TME. STAR-TREC aims to recruit 380 patients to organ preservation and 120 to TME surgery. The primary outcome is the rate of organ preservation at 30 months. Secondary clinician-reported outcomes include acute treatment-related toxicity, rate of non-operative management, non-regrowth pelvic tumour control at 36 months, non-regrowth disease-free survival at 36 months and overall survival at 60 months, and patient-reported toxicity, health-related quality of life at baseline, 12 and 24 months. Exploratory biomarker research uses circulating tumour DNA to predict response and relapse. Discussion: STAR-TREC will prospectively evaluate contrasting therapeutic strategies and implement new measures including a smaller mesorectal target volume, two-step response assessment and non-operative management for complete response. The trial will yield important information to guide routine management of patients with early-stage rectal cancer. |
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| MeSH term(s) | Chemoradiotherapy/methods ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Multicenter Studies as Topic ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/prevention & control ; Organ Preservation ; Patient Preference ; Quality of Life ; Randomized Controlled Trials as Topic ; Rectal Neoplasms/pathology ; Rectum/pathology ; Rectum/surgery ; Treatment Outcome ; Watchful Waiting |
| Language | English |
| Publishing date | 2022-03-24 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article |
| ZDB-ID | 1440017-0 |
| ISSN | 1463-1318 ; 1462-8910 |
| ISSN (online) | 1463-1318 |
| ISSN | 1462-8910 |
| DOI | 10.1111/codi.16056 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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