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Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion pushed from Jan 31, 2028 to Jan 31, 2030v14 Show 4 more changesShow less
    • Enrollment increased: 54 → 64 participants
    • Study completion moved earlier from Jan 31, 2033 to Jan 31, 2032
    • Secondary endpoints: details revised at 2 of 6 entries
    • Eligibility criteria expanded, about 1 word
  2. Study sites: 3 to 4v13
  3. Eligibility criteria expanded, about 40 wordsv12
  4. Site contacts updated at 1 of 3 sitesv11
  5. Site contacts updated at 1 of 3 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria shortened, about 24 wordsv9
  2. Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 1 of 3 sites
    v8
  3. Enrollment target: 76 to 54v7
  4. Study sites: 2 to 3v6
  5. Study sites: 1 to 2v5
  6. Secondary endpoints revised (6)v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2021 to Jan 28, 2021
    • Site details revised
    v3
  8. Start date: Dec 11, 2020 to Jan 31, 2021
    • Primary completion date: Dec 31, 2027 to Jan 31, 2028
    • Study completion date: Dec 31, 2032 to Jan 31, 2033
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Trial Details
NCT Number NCT04643366
Lead Sponsor Virginia Commonwealth University
Conditions
(from sponsor)		 Rectal Cancer
Related terms Rectal Neoplasms
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov