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Intraperitoneal Chemotherapy for Colorectal Cancer (ICARuS Trial)

Phase 2

Waitlist Available

Led By Garrett Nash, MD, MPH

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be planning to undergo complete cytoreduction of all peritoneal disease

Subjects with a history of endometrial cancer are eligible only if they presented with a stage lower than 1A and if the histology was a subtype other than poorly differentiated

Must not have

Subjects with classical carcinoid

Subjects who have previously undergone intraperitoneal chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two methods of chemotherapy - EPIC and HIPEC - to see which is more effective for appendiceal and colorectal cancer.

Who is the study for?

This trial is for adults with appendiceal or colorectal cancer that has spread to the lining of the abdomen, who are fit enough for surgery and have no other serious medical conditions. They must not be pregnant, should agree to use contraception, and cannot have had prior intraperitoneal chemotherapy.

What is being tested?

The study compares two types of chemotherapy given after surgery to remove all visible cancer from the abdomen: EPIC (chemo directly into the abdomen post-surgery) and HIPEC (heated chemo during surgery). It aims to determine their effectiveness against abdominal cancers.

What are the potential side effects?

Possible side effects include reactions to chemotherapy drugs like floxuridine, leucovorin, or mitomycin such as allergic responses, digestive issues, blood cell count changes leading to increased infection risk, fatigue, and potential organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove all cancer from my abdomen.

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I had early-stage endometrial cancer that was not poorly differentiated.

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I am 18 years old or older.

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I have a diagnosis of cancer in my appendix or colon with spread to the lining of my abdomen.

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My kidney function is within the normal range.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with classical carcinoid cancer.

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I have had chemotherapy delivered directly into my abdomen.

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I am allergic to floxuridine, leucovorin, or mitomycin.

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I have heart failure that affects my daily activities.

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My cancer has spread to areas beyond lymph nodes or the lining of my abdomen.

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I do not have severe lung problems that would make participating in the study unsafe for me.

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My blood pressure is higher than 140/90 and I'm not cleared for surgery.

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My surgeon found extensive scar tissue in my abdomen that prevents certain treatments.

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I am not pregnant or breastfeeding.

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I have active heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

disease-free survival

Secondary study objectives

chemotherapy toxicity grade 3 to 5

surgical toxicity grade 3 to 5

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Colorectal, no chemotherapy within 6 months prior to surgeryExperimental Treatment3 Interventions

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the PI or Co-PI. 1. Exposure to chemotherapy in the prior 6 months vs. no such exposure 2. Appendix vs. Colon or Rectum • Then, patients will be randomly assigned in the operating room, by envelope, to either HIPEC (Group A) or EPIC (Group B) after the operating surgeon determines that the patient is optimally cytoreduced to nodules no greater than 2.5mm.

Group II: Colorectal, chemotherapy within 6 months prior to surgeryExperimental Treatment3 Interventions

Group III: Appendiceal, no chemotherapy within 6 months prior to surgeryExperimental Treatment3 Interventions

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the PI or Co-PI. 1. Exposure to chemotherapy in the prior 6 months vs. no such exposure 2. Appendix vs. Colon or Rectum Then, patients will be randomly assigned in the operating room, by envelope, to either HIPEC (Group A) or EPIC (Group B) after the operating surgeon determines that the patient is optimally cytoreduced to nodules no greater than 2.5mm.

Group IV: Appendiceal, chemotherapy within 6 months prior to surgeryExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytoreductive Surgery

2011

Completed Phase 2

~200

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