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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 (ICARuS)

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ClinicalTrials.gov Identifier: NCT01815359
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Last Update Posted : February 2, 2024
Sponsor:
Collaborators:
The Cleveland Clinic
Brigham and Women's Hospital
University of Miami
University of Pittsburgh Medical Center
Washington University School of Medicine
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Appendix Cancer Colorectal Cancer Procedure: Cytoreductive Surgery Drug: HIPEC with Mitomycin-C Drug: EPIC with FUDR and Leucovorin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Appendiceal, no chemotherapy within 6 months prior to surgery

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.
 Procedure: Cytoreductive Surgery
Optimal Surgical Debulking

Drug: HIPEC with Mitomycin-C
Drug: EPIC with FUDR and Leucovorin
Experimental: Appendiceal, chemotherapy within 6 months prior to surgery

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.
 Procedure: Cytoreductive Surgery
Optimal Surgical Debulking

Drug: HIPEC with Mitomycin-C
Drug: EPIC with FUDR and Leucovorin
Experimental: Colorectal, no chemotherapy within 6 months prior to surgery

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.
 Procedure: Cytoreductive Surgery
Optimal Surgical Debulking

Drug: HIPEC with Mitomycin-C
Drug: EPIC with FUDR and Leucovorin
Experimental: Colorectal, chemotherapy within 6 months prior to surgery

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.
 Procedure: Cytoreductive Surgery
Optimal Surgical Debulking

Drug: HIPEC with Mitomycin-C
Drug: EPIC with FUDR and Leucovorin


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. surgical toxicity grade 3 to 5 [ Time Frame: up to 60 days ]
    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

  2. chemotherapy toxicity grade 3 to 5 [ Time Frame: up to 60 days ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815359


Locations
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United States, Florida
University of Miami
Miami, Florida, United States
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester (Consent and Follow up)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Consent and Follow up)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
The Cleveland Clinic
Brigham and Women's Hospital
University of Miami
University of Pittsburgh Medical Center
Washington University School of Medicine
Investigators
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Principal Investigator: Garrett Nash, MD, MPH Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01815359    
Other Study ID Numbers: 12-289
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024
Keywords provided by Memorial Sloan Kettering Cancer Center:
ICARuS
Intraperitoneal Chemotherapy
hyperthermic intraperitoneal chemotherapy
Optimal Surgical Debulking
 Leucovorin
Floxuridine (FUDR)
Mitomycin
12-289
Additional relevant MeSH terms:
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Neoplasms
Appendiceal Neoplasms
Hyperthermia
Fever
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Cecal Neoplasms
 Cecal Diseases
Leucovorin
Mitomycins
Mitomycin
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors