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Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?

Study acronym: STAR-TREC
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary completion date: Apr 2027 to Aug 2027v7
  2. Primary completion date: Aug 2024 to Apr 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v6
  3. Phase: Phase 2 to Phase 2/3v5 Show 10 more changesShow less
    • Enrollment target: 120 to 380
    • Primary completion date: Oct 2021 to Aug 2024
    • Primary endpoints revised (2)
    • Study sites: 3 to 5
    • Study completion date: Oct 2021 to Aug 2028
    • Interventions: Long course concurrent chemoradiation (Drug), Short course radiotherapy (Radiation), Standard TME surgery (Procedure) to Long course concurrent chemoradiation with capecitabine and radiotherapy (Drug), Short course radiotherapy (Radiation), Standard TME…
    • Eligibility criteria expanded, about 106 words
    • Secondary endpoints: 20 to 38
    • Study description expanded, about 151 words
    • Study title revised
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2017 to Jun 14, 2017
    v4
  5. Start date: Nov 2016 to Jun 2017v3
  6. Eligibility criteria shortened, about 4 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bowel cancer is the second most common tumour with 41 000 new cases diagnosed annually in the UK, 447 000 across Europe and 1.36 million worldwide; of which one third are located in the rectum. Standard primary radical Total Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in approximately 10% of cases while many more patients have a temporary stoma, some of which are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic tumours, may not be the optimal method of treatment for early screen-detected tumours and an organ preserving strategy may generate significantly less morbidity without substantially compromising oncological outcomes. STAR-TREC is a rolling phase II/III study. Phase II aimed to assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus two contrasting organ saving treatments followed by selective transanal microsurgery. Phase III will evaluate two contrasting organ preservation strategies in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL).
Trial Details
NCT Number NCT02945566
Lead Sponsor University of Birmingham
Conditions
(from sponsor)		 Adenocarcinoma of the Rectum
Related terms Rectal Neoplasms
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov