Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases

Background:

- Survival rates for colorectal cancer depend on a number of factors, including the
existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in
the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as
patients who had bleeding or obstruction when they were diagnosed, have a high risk of
cancer recurrence even after surgery or other treatment.

- If additional tumors are discovered early and removed while they are still small (often
before they can show up on scans), survival rates may improve. In addition, patients
who receive a heated chemotherapy solution delivered directly to the abdomen often have
better treatment outcomes regardless of whether additional tumors were found. Further
research can help determine the usefulness of both of these treatments in improving the
outcomes of patients with colorectal cancer.

Objectives:

- To determine whether patients who have had surgery for colorectal cancer have improved
outcomes after receiving additional surgery combined with direct chemotherapy, compared with
those who receive the current standard of care.

Eligibility:

- Individuals at least 18 years of age who have had surgery for colorectal cancer within the
past 14 months, who are considered to be at high risk for cancer recurrence, and whose
current imaging scans show no signs of additional tumors.

Design:

- Participants will be divided into two treatment groups: a surgery group and a standard
of care group.

- Participants who had surgery less than 11 months ago will be enrolled in a 3-month
lead-in phase to receive standard follow-up care, including labs, scans, and physical
examinations, before being randomized to a treatment group between 11 and 14 months
after surgery. Participants who had surgery between 11 and 14 months ago will be
randomized at the time of enrollment.

- Participants in the surgery group will have the following procedures within 2 weeks of
randomization:

- Abdominal surgery where surgeons will look for and remove any tumors and take biopsies
to check for cancer cells

- Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen

- In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge.

- Participants in the standard of care group will have the standard follow-up schedule
for high-risk colorectal cancer patients:

- Clinic evaluations every 3 months for 2 year...