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S0820, Adenoma and Second Primary Prevention Trial

Study acronym: PACES
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 1, 2027 to Sep 15, 2027 Site details revised at 2 of 990 sitesv41 Show 1 more changeShow less
    • Site details revised at 2 of 990 sites
  2. Re-verified, no change to tracked fieldsv40
  3. Start date: Mar 1, 2013 to Aug 23, 2013v39
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1340 to confirmed 354 · Secondary endpoints revised (15) · Site details revised at 990 of 990 sitesv38 Show 3 more changesShow less
    • Enrollment target: estimated 1340 to confirmed 354
    • Secondary endpoints revised (15)
    • Site details revised at 990 of 990 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 986 to 990v37
Show 35 earlier versionsHide 35 earlier versions
  1. Start date: Mar 2013 to Mar 1, 2013v36
  2. Primary completion date: Jul 2025 to Feb 1, 2027 Completion date: Jul 2029 to Feb 1, 2032v35 Show 1 more changeShow less
    • Completion date: Jul 2029 to Feb 1, 2032
  3. Study sites: 978 to 986v34
  4. Study sites: 975 to 978v33
  5. Re-verified, no change to tracked fieldsv32
  6. Study sites: 970 to 975v31
  7. Study sites: 963 to 970v30
  8. Primary endpoint revised Secondary endpoints: 6 to 15v29 Show 1 more changeShow less
    • Secondary endpoints: 6 to 15

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 953 to 963v28
  10. Study sites revised (953)v27 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 947 to 953v26
  12. Primary endpoint revised Eligibility criteria expanded, about 55 words · Secondary endpoints: 5 to 6 · Study description shortened, about 12 wordsv25 Show 3 more changesShow less
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 925 to 947v24
  14. Primary completion date: Jun 2024 to Jul 2025 Completion date: Jun 2029 to Jul 2029v23 Show 1 more changeShow less
    • Completion date: Jun 2029 to Jul 2029
  15. Study sites: 916 to 925v22
  16. Study sites: 892 to 916v21
  17. Study sites: 835 to 892v20
  18. Study sites: 729 to 835v19
  19. Primary completion date: Jul 2016 to Jun 2024 Completion date: Jul 2019 to Jun 2029v18 Show 1 more changeShow less
    • Completion date: Jul 2019 to Jun 2029
  20. Re-verified, no change to tracked fieldsv17
  21. Study sites: 689 to 729v16
  22. Study sites: 600 to 689 Eligibility criteria expanded, about 59 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 59 words

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 568 to 600v14
  24. Study sites: 507 to 568v13
  25. Study sites: 492 to 507v12
  26. Study sites: 426 to 492v11
  27. Study sites: 271 to 426v10
  28. Study sites: 145 to 271v9
  29. Trial status: Active, Not Recruiting to Recruiting Study sites: 0 to 145v8 Show 1 more changeShow less
    • Study sites: 0 to 145
  30. Trial status: Not Yet Recruiting to Active, Not Recruiting Start date: Jan 2013 to Mar 2013 · Secondary endpoints: details revised at 1 of 5 entriesv7 Show 2 more changesShow less
    • Start date: Jan 2013 to Mar 2013
    • Secondary endpoints: details revised at 1 of 5 entries
  31. Start date: Oct 2012 to Jan 2013v6
  32. Start date: Apr 2012 to Oct 2012 Interventions: Eflornithine & sulindac (Drug), Eflornithine placebo & sulindac (Drug), Eflornithine placebo & sulindac placebo (Drug), eflornithine… to Eflornithine placebo & sulindac (Drug), Eflornithine placebo & sulindac placebo (Drug), Eflornithine plus sulindac (Drug), eflornithine &…v5 Show 1 more changeShow less
    • Interventions: Eflornithine & sulindac (Drug), Eflornithine placebo & sulindac (Drug), Eflornithine placebo & sulindac placebo (Drug), eflornithine… to Eflornithine placebo & sulindac (Drug), Eflornithine placebo & sulindac placebo (Drug), Eflornithine plus sulindac (Drug), eflornithine &…
  33. Start date: Apr 2012v4
  34. Study title expanded, about 1 wordv3 See this version in full on ClinicalTrials.gov ↗
  35. Collaborators: 1 to 2v2 See this version in full on ClinicalTrials.gov ↗
  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 investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.
Trial Details
NCT Number NCT01349881
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI), Cancer Prevention Pharmaceuticals, Inc.
Conditions Colorectal Neoplasms
Enrollment 354 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov