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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
Optimal Surgical Debulking
University of Miami
Miami, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent and Follow up)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent and Follow up)
Uniondale, New York, United States
disease-free survival
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.
Time frame: 3 years
surgical toxicity grade 3 to 5
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
Time frame: up to 60 days
chemotherapy toxicity grade 3 to 5
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.
Time frame: up to 60 days
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