In a nutshell
This study will compare two procedures to deliver chemotherapy into the abdominal cavity following surgery to remove colorectal cancer spread to the peritoneum (the lining of the abdominal cavity). The primary outcome of the study is disease-free survival, or the length of time without any evidence of cancer.
The details
Colorectal cancers spread to the peritoneum (the lining of the abdominal cavity) are sometimes treated with a procedure called "cytoreductive surgery". This technique involves the removal of the primary colorectal tumor, followed by careful inspection and removal of all visible metastases in the peritoneum. Since cancers treated in this fashion are usually very advanced, chemotherapy is delivered to the abdominal cavity following surgery, to destroy any remaining cancer cells (not visible for removal).
The study investigates the use of two procedures to deliver chemotherapy following cytoreductive surgery.
Currently, the standard procedure used is "hyperthermic intraperitoneal chemotherapy", or HIPEC. This involves the continuous infusion of a warmed chemotherapy solution into the abdomen immediately following surgery, for a maximum of 2 hours. Afterwards, the surgical incision is closed.
Another technique that can be used is "early post-operative intraperitoneal chemotherapy", or EPIC. It involves placing a catheter through which several cycles of chemotherapy will be delivered in the days following cytoreductive surgery.
Who are they looking for?
Researchers are looking for about 220 patients with confirmed cancer of the colon, rectum or appendix which has spread only to the peritoneum. Participants should be candidates for complete cytoreductive surgery, in very good general health, with normal or near-normal results on their blood tests. Patients should have no uncontrolled heart or lung disease or any life-threatening condition that would raise the surgical risk. Candidates (both men and women) should also agree to use effective contraception for the entire length of the trial.
Exclusion criteria for the study include having had previous cytoreductive surgery, intraperitoneal chemotherapy or radiation therapy to the abdomen. Patients cannot participate if they have carcinoid tumors, cancer spread beyond the peritoneum, history of other cancers, HIV or hepatitis B/C infection. Depending on individual circumstances, a history of previous abdominal surgeries may also limit participation in the trial.
How will it work
Patients undergoing cytoreductive surgery will be randomly assigned to receive either HIPEC or EPIC. Participants will also be assigned to one of 4 groups, according to the organ from which the cancer originated and previous chemotherapy use:
- One group: appendiceal cancer, no chemotherapy within 6 months prior to surgery
- A second group: appendiceal cancer and chemotherapy received within 6 months prior to surgery
- A third group: colorectal cancer, no chemotherapy within 6 months prior to surgery
- Fourth group: colorectal cancer and chemotherapy received within 6 months prior to surgery
The main objective of the study is to evaluate disease-free survival across the 4 groups and according to the intraperitoneal chemotherapy method used. Documentation of tumor recurrence will be made based on surveillance CT scans as determined by the attending radiologist and treating physician. Secondary outcomes to be investigated include surgical complications and chemotherapy-related adverse effects (toxicity).
Clinical trial locations
| Type: | Interventional |
| Participants: | 282 |
| Study ID: | NCT01815359 |
