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Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

Study acronym: TiMiSNAR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 16, 2024 (before its estimated June 5, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 5, 2024 to Jun 5, 2025
    • Study sites: 13 to 14
    v21
  2. Enrollment target: 332 to 340
    • Study sites: 16 to 13
    v20
  3. Primary completion date: Jun 5, 2023 to Jun 5, 2024
    • Study sites: 15 to 16
    • Study completion date: Jun 5, 2028 to Jun 5, 2029
    v19
  4. Re-verified, no change to tracked fieldsv18
  5. Study sites: 11 to 15v17
Show 15 earlier versionsHide 15 earlier versions
  1. Site details revised at 1 of 11 sitesv16
  2. Study sites: 8 to 11v15
  3. Re-verified, no change to tracked fieldsv14
  4. Site details revised at 1 of 8 sitesv13
  5. Study sites: 7 to 8v12
  6. Study sites: 6 to 7v11
  7. Study sites: 5 to 6v10
  8. Site details revised at 1 of 5 sitesv9
  9. Study sites: 4 to 5v8
  10. Study sites: 1 to 4v7
  11. Re-verified, no change to tracked fieldsv6
  12. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: May 30, 2023 to Jun 5, 2023
    • Study completion date: May 30, 2028 to Jun 5, 2028
    • Start date changed from estimate of May 30, 2018 to Jun 5, 2018
  13. 2 versions Re-verified since May 9, 2018, no change to tracked fieldsv3-v4
  14. Start date: Mar 30, 2018 to May 30, 2018
    • Primary completion date: Mar 30, 2023 to May 30, 2023
    • Study completion date: Mar 30, 2028 to May 30, 2028
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.
Trial Details
NCT Number NCT03465982
Lead Sponsor Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Conditions
(from sponsor)		 Rectal Cancer
Related terms Colorectal Neoplasms, Rectal Neoplasms
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov