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Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. 2 versions Re-verified since Dec 11, 2024, no change to tracked fieldsv9-v10
  2. Results first posted: Sep 11, 2023
    • Enrollment target: estimated 40 to confirmed 12
    • Secondary endpoints revised (4)
    • Primary endpoint revised
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v6
  5. Study title revisedv5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 1 of 2 sitesv4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Feb 1, 2019 to May 3, 2019
    • Study sites: 1 to 2
    • Primary completion date: Feb 1, 2022 to Jun 1, 2022
    • Study completion date: Feb 1, 2027 to Jun 1, 2027
  3. Study sites: 0 to 1v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.
Trial Details
NCT Number NCT03781323
Lead Sponsor University of Rochester
Conditions
(from sponsor)		 Advanced Rectal Cancer
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov