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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

ICARuS Trial 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.Check my eligibility

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.See study design

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.

ICARuS Trial 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.

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

My kidney function is within the normal range.

Select...

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

ICARuS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

disease-free survival

Secondary outcome measures

chemotherapy toxicity grade 3 to 5

surgical toxicity grade 3 to 5

ICARuS 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. Exposure to chemotherapy in the prior 6 months vs. no such exposure 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. Exposure to chemotherapy in the prior 6 months vs. no such exposure 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 1

~150

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,328 Total Patients Enrolled

The Cleveland ClinicOTHER

1,026 Previous Clinical Trials

1,365,784 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,608 Previous Clinical Trials

11,469,585 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any subjects still needed for this research?

"Yes, the trial is still ongoing and looking for participants. According to the clinicaltrials.gov website, this trial was first posted on March 1st, 2013 and was last edited on May 18th, 2022. They are looking for a total of 282 patients from 8 different sites."

Answered by AI

What other types of medical research studies have included Cytoreductive Surgery?

"Presently, there are a total of 323 clinical trials underway that focus on Cytoreductive Surgery. Phase 3 trials, which are the most advanced, account for 98 of those live trials. The majority of studies are based in Woolloongabba, Queensland, but Cytoreductive Surgery trials are taking place at 18483 locations worldwide."

Answered by AI

What does Cytoreductive Surgery usually help to improve?

"Cytoreductive Surgery is a commonly used treatment for cervical cancer, but can also be used to manage low-grade upper tract urothelial cancer (lg-utuc), glaucoma, and hiv."

Answered by AI

Does Cytoreductive Surgery have a high success rate?

"Cytoreductive Surgery received a score of 2 on our 1-3 Power scale. This is due to the fact that this is only a Phase 2 trial, meaning that while there is some data supporting safety, there is no data indicating that the surgery is effective."

Answered by AI