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

This study is currently recruiting participants.
Verified January 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01815359
First received: March 13, 2013
Last updated: January 2, 2014
Last verified: January 2014

March 13, 2013
January 2, 2014
March 2013
March 2018   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01815359 on ClinicalTrials.gov Archive Site
  • surgical toxicity grade 3 to 5 [ Time Frame: up to 60 days ] [ Designated as safety issue: Yes ]
    We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 complications 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 4 or 5 [ Time Frame: up to 60 days ] [ Designated as safety issue: Yes ]
    We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 toxicity or chemotherapy related Grade 4 or 5 toxicities.
  • surgical toxicity grade 3 to 5 [ Time Frame: up to 60 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    We will evaluate toxicity up to 60 days postoperatively for any surgical Grade 3-5 toxicity or chemotherapy related Grade 4 or 5 toxicities.
Not Provided
Not Provided
 
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 (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Single-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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Appendix Cancer
  • Colorectal Cancer
  • Procedure: Cytoreductive Surgery
    Optimal Surgical Debulking
  • Drug: HIPEC with Mitomycin-C
  • Drug: EPIC with FUDR and Leucovorin
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
March 2018
March 2018   (final data collection date for primary outcome measure)

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 > 100,000/ 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 complete cytoreduction and/or intraperitoneal chemotherapy.
  • Subjects with classical carcinoid
  • Tumors of low malignant potential
  • Subjects who have received prior radiation to any portion of the abdominal cavity or pelvis are excluded.

Other prior malignancies, except for cured non-melanoma skin cancer, or curatively treated in situ carcinoma of the cervix, or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.

  • 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.
  • Known HIV, Hepatitis B or Hepatitis C positive.
  • 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 30 days of enrollment.

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.
  • Life expectancy < 12 weeks.
Both
18 Years and older
No
Contact: Garrett Nash, MD, MPH 646-888-3086
Contact: Andrea Cercek, MD 646-888-4189
United States
 
NCT01815359
12-289
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Garrett Nash, MD, MPH Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

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