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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 : Recruiting
First Posted : March 21, 2013
Last Update Posted : September 26, 2019
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

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE March 21, 2013
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
disease-free survival [ Time Frame: 3 years ]
Documentation of tumor recurrence will be made based on surveillance CT scans at time points as determined by attending radiologist, with clinical correlation from the treating physician.
Change History Complete list of historical versions of study NCT01815359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
  • surgical toxicity grade 3 to 5 [ Time Frame: up to 60 days ]
    We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 toxicity or chemotherapy related Grade 4 or 5 toxicities.
  • chemotherapy toxicity grade 4 or 5 [ Time Frame: up to 60 days ]
    We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 toxicity or chemotherapy related Grade 4 or 5 toxicities.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Appendix Cancer
  • Colorectal Cancer
Intervention  ICMJE
  • Procedure: Cytoreductive Surgery
    Optimal Surgical Debulking
  • Drug: HIPEC with Mitomycin-C
  • Drug: EPIC with FUDR and Leucovorin
Study Arms  ICMJE
  • 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 Colorectal Disease Management Team.

    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.
    Interventions:
    • Procedure: Cytoreductive Surgery
    • 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 Colorectal Disease Management Team.

    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.
    Interventions:
    • Procedure: Cytoreductive Surgery
    • 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 Colorectal Disease Management Team.

    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.
    Interventions:
    • Procedure: Cytoreductive Surgery
    • 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 Colorectal Disease Management Team.

    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.
    Interventions:
    • Procedure: Cytoreductive Surgery
    • Drug: HIPEC with Mitomycin-C
    • Drug: EPIC with FUDR and Leucovorin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
282
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2013)
220
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Garrett Nash, MD, MPH 212-639-8668
Contact: Andrea Cercek, MD 646-888-4189
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01815359
Other Study ID Numbers  ICMJE 12-289
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • The Cleveland Clinic
  • Brigham and Women's Hospital
  • University of Miami
  • University of Pittsburgh Medical Center
  • Washington University School of Medicine
Investigators  ICMJE
Principal Investigator: Garrett Nash, MD, MPH Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP