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Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer

Study acronym: SHAPERS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 19 sitesv7
  2. Interventions: Adjuvant chemotherapy (optional) (Drug), Short course radiotherapy (Radiation), Total mesorectal excision (Procedure), Total neoadjuvant… to Adjuvant chemotherapy (optional) (Drug), Long course chemoradiotherapy (Radiation), Short course radiotherapy (Radiation), Total mesorectal… Eligibility criteria expanded, about 8 words · Study description expanded, about 50 words · Site details revised at 6 of 19 sites · 1 morev6 Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 50 words
    • Site details revised at 6 of 19 sites
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 3 of 19 sitesv5
  4. Study sites: 14 to 19v4
  5. Study sites: 13 to 14v3
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2023 to Feb 7, 2024 · Site details revised at 13 of 13 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2023 to Feb 7, 2024
    • Site details revised at 13 of 13 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.
Trial Details
NCT Number NCT06052332
Lead Sponsor Jules Bordet Institute
Conditions Locally Advanced Rectal Cancer, Older People
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov