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
NCT01815359 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 292
Last updated 2026-02-05
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.
Conditions
- Appendix Cancer
- Colorectal Cancer
Interventions
- PROCEDURE
-
Cytoreductive Surgery
Optimal Surgical Debulking
- DRUG
-
HIPEC with Mitomycin-C
- DRUG
-
EPIC with FUDR and Leucovorin
Sponsors & Collaborators
-
The Cleveland Clinic
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER -
University of Miami
collaborator OTHER -
University of Pittsburgh Medical Center
collaborator OTHER -
Washington University School of Medicine
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Garrett Nash, MD, MPH · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- United States
Study Locations
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