Appendix CancerPhase 2ICARuSNCT01815359
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
A Phase 2 study testing Cytoreductive Surgery, HIPEC with Mitomycin-C and EPIC with FUDR and Leucovorin in people with Appendix Cancer and Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
This is the first randomized trial comparing Early post-operative intraperitoneal chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendix Cancer, Colorectal Cancer
- What is being tested?
- Cytoreductive Surgery, HIPEC with Mitomycin-C and EPIC with FUDR and Leucovorin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2013to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's age 18 years or older, both genders.
- Clinical diagnosis of appendiceal or colorectal neoplasm with peritoneal mucinosis or metastasis.
- Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
- ECOG performance status ≤ 1.
- Hematology: ANC ≥ 1,500/ μL; Platelets > 75,000/ μL.
- Adequate Renal function Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml/min.
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- Adequate Hepatic function: Bilirubin less than 1.5mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL).
- Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- A man participating in this study must agree to utilize reliable barrier form of contraception for the duration of the study.
- Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
- 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.
Who cannot join
- Subjects who have previously undergone intraperitoneal chemotherapy.
- Subjects with classical carcinoid
- Tumors of low malignant potential
- Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than 3 years or indolent tumors for which observation over three years is a reasonable option.
- Presence of clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces.
- Women who are pregnant or lactating.
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- Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
- Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment and/or were cleared by MSK cardiology.
- Uncontrolled hypertension defined as >140/90 and not cleared for surgery at the time of consent.
- New York Heart Association (NYHA) Class II or higher Congestive heart failure.
- Restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- History of cerebrovascular disease. that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study.
- Patients with known floxuridine, leucovorin ,or mitomycin allergy.
- Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
- Any condition that would preclude the ability to deliver appropriate IP therapy.
- Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.
- Life expectancy < 12 weeks.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Follow up)
Harrison, New York, 10604
University of Miami
Miami, Florida
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110
Memorial Sloan Kettering Nassau (Consent and Follow up)
Uniondale, New York, 11553
About this study
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
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
- Being tested
- Cytoreductive Surgery, HIPEC with Mitomycin-C, EPIC with FUDR and Leucovorin
- Keywords
- ICARuS, Intraperitoneal Chemotherapy, hyperthermic intraperitoneal chemotherapy, Optimal Surgical Debulking, Leucovorin, Floxuridine (FUDR), Mitomycin, 12-289
- Medical subject headings
- Appendiceal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive SurgeryProcedure or surgery
Optimal Surgical Debulking
HIPEC with Mitomycin-CDrug
EPIC with FUDR and LeucovorinDrug
| Study group | Role | What they receive |
|---|---|---|
| Appendiceal, no chemotherapy within 6 months prior to surgery | Experimental | 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. Receives: Procedure: Cytoreductive Surgery; Drug: HIPEC with Mitomycin-C; Drug: EPIC with FUDR and Leucovorin |
| Appendiceal, chemotherapy within 6 months prior to surgery | Experimental | 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. Receives: Procedure: Cytoreductive Surgery; Drug: HIPEC with Mitomycin-C; Drug: EPIC with FUDR and Leucovorin |
| Colorectal, no chemotherapy within 6 months prior to surgery | Experimental | 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. Receives: Procedure: Cytoreductive Surgery; Drug: HIPEC with Mitomycin-C; Drug: EPIC with FUDR and Leucovorin |
| Colorectal, chemotherapy within 6 months prior to surgery | Experimental | 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. Receives: Procedure: Cytoreductive Surgery; Drug: HIPEC with Mitomycin-C; Drug: EPIC with FUDR and Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Documentation of tumor recurrence will be made based on surveillance CT/PET CT scans at time points as determined by attending radiologist, with clinical correlation from the treating physician.
Measured: 3 years
Secondary outcomes (2)
surgical toxicity grade 3 to 5
We will evaluate toxicity up to 30 days postoperatively for any surgical Grade 3-5 complications/toxicites or chemotherapy related Grade 4 or 5 toxicities. Surgical morbidity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: up to 60 days
chemotherapy toxicity grade 3 to 5
We will evaluate toxicity up to 30 days postoperatively for any surgical Grade 3-5 complications/toxicities or chemotherapy related Grade 4 or 5 toxicities.
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendix CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- After the initial 212 patients are accrued, the final 70 patients will be accrued to only the appendiceal cohorts
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Brigham and Women's Hospital, University of Miami, University of Pittsburgh Medical Center, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Garrett Nash, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815359
- Sponsor's protocol ID
- 12-289
- Acronym
- ICARuS
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2013
- Last updated
- 2 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01815359
- Acronym / sponsor ID
- ICARuS / 12-289
- Conditions
- Appendix Cancer, Colorectal Cancer
- Keywords
- ICARuS, Intraperitoneal Chemotherapy, hyperthermic intraperitoneal chemotherapy, Optimal Surgical Debulking, Leucovorin, Floxuridine (FUDR), Mitomycin, 12-289
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Brigham and Women's Hospital, University of Miami, University of Pittsburgh Medical Center, Washington University School of Medicine
- Study start
- Mar 2013
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After the initial 212 patients are accrued, the final 70 patients will be accrued to only the appendiceal cohorts
| Arm | Type | Receives |
|---|---|---|
| Appendiceal, no chemotherapy within 6 months prior to surgery | Experimental | Procedure: Cytoreductive Surgery, Drug: HIPEC with Mitomycin-C, Drug: EPIC with FUDR and LeucovorinFirst, 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. |
| Appendiceal, chemotherapy within 6 months prior to surgery | Experimental | Procedure: Cytoreductive Surgery, Drug: HIPEC with Mitomycin-C, Drug: EPIC with FUDR and LeucovorinFirst, 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. |
| Colorectal, no chemotherapy within 6 months prior to surgery | Experimental | Procedure: Cytoreductive Surgery, Drug: HIPEC with Mitomycin-C, Drug: EPIC with FUDR and LeucovorinFirst, 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. |
| Colorectal, chemotherapy within 6 months prior to surgery | Experimental | Procedure: Cytoreductive Surgery, Drug: HIPEC with Mitomycin-C, Drug: EPIC with FUDR and LeucovorinFirst, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient's age 18 years or older, both genders.
- Clinical diagnosis of appendiceal or colorectal neoplasm with peritoneal mucinosis or metastasis.
- Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
- ECOG performance status ≤ 1.
- Hematology: ANC ≥ 1,500/ μL; Platelets > 75,000/ μL.
Key exclusion criteria (19 listed)
- Subjects who have previously undergone intraperitoneal chemotherapy.
- Subjects with classical carcinoid
- Tumors of low malignant potential
- Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than 3 years or indolent tumors for which observation over three years is a reasonable option.
- Presence of clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytoreductive SurgeryOptimal Surgical Debulking | Procedure or surgery | Appendiceal, chemotherapy within 6 months prior to surgery, Appendiceal, no chemotherapy within 6 months prior to surgery, Colorectal, chemotherapy within 6 months prior to surgery, Colorectal, no chemotherapy within 6 months prior to surgery |
| HIPEC with Mitomycin-C | Drug | Appendiceal, chemotherapy within 6 months prior to surgery, Appendiceal, no chemotherapy within 6 months prior to surgery, Colorectal, chemotherapy within 6 months prior to surgery, Colorectal, no chemotherapy within 6 months prior to surgery |
| EPIC with FUDR and Leucovorin | Drug | Appendiceal, chemotherapy within 6 months prior to surgery, Appendiceal, no chemotherapy within 6 months prior to surgery, Colorectal, chemotherapy within 6 months prior to surgery, Colorectal, no chemotherapy within 6 months prior to surgery |
Primary outcome
disease-free survival
Time frame: 3 years
Documentation of tumor recurrence will be made based on surveillance CT/PET CT scans at time points as determined by attending radiologist, with clinical correlation from the treating physician.
2 secondary outcomes
surgical toxicity grade 3 to 5
Time frame: up to 60 days
chemotherapy toxicity grade 3 to 5
Time frame: up to 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garrett Nash, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytoreductive Surgery, HIPEC with Mitomycin-C and EPIC with FUDR and Leucovorin in people with Appendix Cancer and Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.