Full TitleICARuS (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
Giving chemotherapy directly into the abdomen after surgery is is a widely practiced treatment for cancers of the appendix, colon, or rectum that have spread to the abdominal lining (peritoneum). It is given to kill any lingering cancer cells and reduce the chance of a recurrence or further cancer spread. In this study, researchers are comparing two forms of such “intraperitoneal” chemotherapy given after surgery for patients with these cancers. Patients will be randomly assigned to receive one form of chemotherapy or the other, but not both.
One group of patients will receive early post-operative intraperitoneal chemotherapy (EPIC), in which the drugs floxuridine and leucovorin are delivered through a catheter into the abdomen for three days. Patients stay in the hospital during this time to both receive the chemotherapy and recover from the surgery.
The second group of patients will receive heated (hyperthermic) intraperitoneal chemotherapy (HIPEC), using the drug mitomycin, which is delivered into the abdomen through a catheter for 100 minutes after the tumor removal surgery is completed. Heating the chemotherapy may sensitize cancer cells to the effects of the chemotherapy.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have cancer of the appendix, colon, or rectum that has spread to the peritoneum and will be surgically removed.
- Patients may not participate if they already had surgery with intraperitoneal chemotherapy, or radiation therapy to the abdomen or pelvis.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is open to patients age 18 and older.