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

No results posted yet for this 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.

Conditions

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01815359 on ClinicalTrials.gov