Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: ICARuS (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multi-center, Randomized Phase II Trial of Early Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitonea

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 Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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:

  • 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.


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: March 13, 2013
Date Started: March 2013
Date Completion: March 2018
Last Updated: March 16, 2017
Last Verified: March 2017