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ACTIVE NOT RECRUITING
NCT01815359
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: ICARuS (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multi-center, Randomized Phase II Trial of Early 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

292

Start Date

2013-03

Completion Date

2026-09

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

PROCEDURE

Cytoreductive Surgery

Optimal Surgical Debulking

DRUG

HIPEC with Mitomycin-C

DRUG

EPIC with FUDR and Leucovorin

Locations (9)

University of Miami

Miami, Florida, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Basking Ridge (Consent and Follow up)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and Follow up)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent and Follow up)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent and Follow up)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent and Follow up)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Consent and Follow up)

Uniondale, New York, United States