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
United States292 participantsStarted 2013-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 chemothe…