Neoplasms

Symptoms and General Pathology

All Conditions

Wounds and Injuries

Digestive System Diseases

Behaviors and Mental Disorders

Neoplasm Metastasis

Hyperthermia

Fever

Appendiceal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Cecal Neoplasms

Cecal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Anti-Infective Agents

Herbal and Botanical

Vitamins

Leucovorin

Mitomycins

Mitomycin

Floxuridine

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Cola

Folate

Vitamin B9

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the PI or Co-PI.

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.

First, patients will be stratified by previous systemic chemotherapy and by the organ of origin as determined by the PI or Co-PI.

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.

Cytoreductive Surgery

HIPEC with Mitomycin-C

EPIC with FUDR and Leucovorin

Garrett Nash, MD, MPH

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.

After the initial 212 patients are accrued, the final 70 patients will be accrued to only the appendiceal cohorts

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 Multi-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

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.

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

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.

Spots Global Cancer Trial Database for optimal surgical debulking