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NCT01815359 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Colorectal Cancer and Appendix Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 292
- Enrollment target
- 9
- Study locations
NCT01815359: Active Phase 2 study of Colorectal Cancer and Appendix Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01815359 is a Phase 2 study of Colorectal Cancer and Appendix Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 292 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (81% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815359, a Phase 2 study of Colorectal Cancer and Appendix Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 292 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Primary Outcome
Documentation of tumor recurrence will be made based on surveillance CT/PET CT scans at time points as determined by attending radiologist, with clinical correlation from the treating physician.
Conditions Studied
Interventions
- PROCEDURE Cytoreductive Surgery
- DRUG HIPEC with Mitomycin-C
- DRUG EPIC with FUDR and Leucovorin
Study Locations (9)
New York
- Memorial Sloan Kettering Commack (Consent and Follow up) - Commack
- Memorial Sloan Kettering Westchester (Consent and Follow up) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Consent and Follow up) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Consent and Follow up) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent and Follow up) - Middletown
- Memorial Sloan Kettering Bergen (Consent and Follow up) - Montvale
Florida
- University of Miami - Miami
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2013-03 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What the registry record for NCT01815359 still lists
NCT01815359 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cytoreductive Surgery is the first listed.
NCT01815359 lists 9 locations in 4 states (New York, New Jersey, Florida).
Frequently Asked Questions
What is clinical trial NCT01815359 about?
NCT01815359 is a clinical study titled "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". 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 cytoreductiv...
What is the current status of trial NCT01815359?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 292 participants. The study started on 2013-03. Estimated completion is 2026-09.
What conditions does trial NCT01815359 study?
This clinical trial studies the following conditions: Colorectal Cancer, Appendix Cancer.
What interventions are being tested in trial NCT01815359?
The interventions under investigation include: Cytoreductive Surgery (PROCEDURE), HIPEC with Mitomycin-C (DRUG), EPIC with FUDR and Leucovorin (DRUG).
Who is sponsoring clinical trial NCT01815359?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01815359 being conducted?
This trial has 9 study locations across Florida, Missouri, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01815359's enrollment target sits among peer trials
292 118th of 381 higher than 263 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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