ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis

Study acronym: ICARuS
StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Collaborators: details revised at 1 of 5 entries
  2. 2 versions Re-verified since Feb 3, 2025, no change to tracked fieldsv40-v41
  3. Primary and study completion dates: Sep 2025 to Sep 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v39
  4. Primary and study completion dates: Sep 2023 to Sep 2025v38
  5. Enrollment target: 282 to 292v37
Show 35 earlier versionsHide 35 earlier versions
  1. Re-verified, no change to tracked fieldsv36
  2. Primary and study completion dates: Sep 2022 to Sep 2023v35
  3. Re-verified, no change to tracked fieldsv34
  4. Primary and study completion dates: Sep 2021 to Sep 2022v33
  5. Re-verified, no change to tracked fieldsv32
  6. Eligibility criteria revisedv31
  7. Primary and study completion dates: Sep 2020 to Sep 2021
    • Study sites: 10 to 9
    v30
  8. Enrollment target: 220 to 282
    • Study sites revised (10)
    v29
  9. Study sites: 9 to 10v28
  10. Primary and study completion dates: Sep 2019 to Sep 2020
    • Site details revised at 1 of 9 sites
    v27
  11. Primary and study completion dates: Mar 2019 to Sep 2019
    • Collaborators revised (5)
    v26
  12. Study sites: 8 to 9v25
  13. Eligibility criteria expanded, about 4 wordsv24
  14. Re-verified, no change to tracked fieldsv23
  15. Primary and study completion dates: Mar 2018 to Mar 2019
    • Study sites: 7 to 8
    v22
  16. Study sites: 5 to 7v21
  17. Study sites: 6 to 5v20
  18. Study sites: 5 to 6v19
  19. Eligibility criteria revisedv18
  20. Study sites: 6 to 5
    • Collaborators: 4 to 5
    v17
  21. Secondary endpoints revised (2)
    • Site contacts updated at 6 of 6 sites
    • Collaborators: 3 to 4
    v16
  22. Re-verified, no change to tracked fieldsv15
  23. Collaborators expanded, about 10 words
    • Eligibility criteria shortened, about 3 words
    v14
  24. Study sites revised (6)v13
  25. Study sites: 5 to 6v12
  26. Eligibility criteria shortened, about 17 words
    • Secondary endpoints: details revised at 2 of 2 entries
    v11
  27. Study sites: 1 to 5
    • Eligibility criteria expanded, about 32 words
    v10
  28. 4 versions Re-verified since Oct 9, 2013, no change to tracked fieldsv6-v9
  29. Interventions: Cytoreductive Surgery (Procedure), EPIC with FUDR and Leucovorin (Drug), HIPEC with MMC (Drug) to Cytoreductive Surgery (Procedure), EPIC with FUDR and Leucovorin (Drug), HIPEC with Mitomycin-C (Drug)
    • Secondary endpoints: details revised at 1 of 2 entries
    v5
  30. Eligibility criteria revised
    • Study title expanded, about 1 word
    v4
  31. Interventions: Cytoreductive Surgery (Procedure), EPIC with FUDR (Drug), HIPEC with MMC (Drug) to Cytoreductive Surgery (Procedure), EPIC with FUDR and Leucovorin (Drug), HIPEC with MMC (Drug)
    • Eligibility criteria expanded, about 1 word
    v3
  32. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • 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 the first randomized trial comparing Early post-operative intraperitoneal chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and colorectal cancer. The purpose of this study is to find out what effects, good and/or bad, EPIC and HIPEC after cytoreductive surgery have on the patient and the appendiceal, rectal or colon cancer.
Trial Details
NCT Number NCT01815359
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: The Cleveland Clinic, Brigham and Women's Hospital, University of Miami, University of Pittsburgh Medical Center, Washington University School of Medicine
Conditions
(from sponsor)		 Appendix Cancer, Colorectal Cancer
Related terms Appendiceal Neoplasms, Colorectal Neoplasms
Enrollment 292 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov