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
- Patient's age 18 years or older, both genders.
- Clinical diagnosis of appendiceal or colorectal neoplasm with peritoneal mucinosis or
- 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
- 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
- Subjects who have previously undergone complete cytoreduction and/or intraperitoneal
- 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
- 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
- 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.