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Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Study acronym: NEO-RT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 109 → 113 locationsv21
  2. Study sites: 107 to 109v20
  3. Study sites: 105 to 107v19
  4. Trial sites expanded: 100 → 105 locationsv18
  5. Study sites: 92 to 100v17
Show 15 earlier versionsHide 15 earlier versions
  1. Eligibility criteria expanded, about 10 wordsv16
  2. Study sites: 79 to 92v15
  3. Study sites: 68 to 79v14
  4. Eligibility criteria expanded, about 28 words
    • Secondary endpoints revised (11)
    v13
  5. Study sites: 57 to 68v12
  6. Study sites: 53 to 57v11
  7. Study sites: 50 to 53v10
  8. Study sites: 32 to 50v9
  9. Study sites: 22 to 32v8
  10. Re-verified, no change to tracked fieldsv7
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 31, 2024 to Jun 26, 2024
    • Site details revised at 22 of 22 sites
    v6
  12. Start date: May 31, 2024 to Jul 31, 2024
    • Study sites: 11 to 22
    v5
  13. Start date: Apr 30, 2024 to May 31, 2024
    • Study sites: 8 to 11
    v4
  14. Start date: Mar 30, 2024 to Apr 30, 2024
    • Study sites: 0 to 8
    v3
  15. Start date: Jan 30, 2024 to Mar 30, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
Trial Details
NCT Number NCT06205485
Lead Sponsor Canadian Cancer Trials Group
Collaborators: Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, SWOG Cancer Research Network
Conditions
(from sponsor)		 Rectal Cancer
Related terms Rectal Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov