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

INCLUSION CRITERIA:

Histologically confirmed colorectal adenocarcinoma.

Curative resection (NED at closure) for CRC which was (1) perforated into the peritoneal cavity, (2) associated with minimal PC which was completely excised at the time of initial operation, (3) T4 lesion that required en bloc resection of additional organs, (4) associated with ovarian metastases or (5) emergency presentation with lesions associated with obstruction and/or bleeding.

Note: Patient who presented at the time of diagnosis with limited extra abdominal metastases may be eligible if the lesions were completely resected and the patient remains NED.

Received at least 3 months of standard of care adjuvant therapy and is disease free by conventional imaging at time of registration and/or randomization.

Note: The imaging will be reviewed by an experienced radiologist and a surgical attending prior to enrollment.

Greater than or equal to 18 years of age.
Must be able to understand and sign the Informed Consent
Clinical performance status of ECOG less than or equal to 2.
Life expectancy of greater than three months.
Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy.
Hematology:
Absolute neutrophil count greater than 1500/mm(3) without the support of Filgrastim.
Platelet count greater than 75,000/mm(3).

Hemoglobin greater than 8.0 g/dl.

j. Chemistry:

Serum creatinine less than or equal to 1.5 mg/dl unless the measured creatinine clearance is greater than 60mL/min/1.73m(2).

Total bilirubin less than or equal to 2 mg/dl, except for patients with diagnosis of Gilbert's disease or hepatic pedicle obstruction then total bilirubin must be less than or equal to 5 mg/dl.

k. INR less than or equal to 1.8.

l. Stable serum CEA levels

m. No history of prior/other malignancies within the 2 years prior to enrollment with the exception of basal cell carcinoma.

EXCLUSION CRITERIA:

Women of child-bearing potential who are pregnant or breast feeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
Active systemic infections, coagulation disorders or other major medical illnesses precluding major surgery.
Prior experimental therapy with novel agents
Prior HIPEC
History of brain metastases
Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies or with evidence of moderate to severe ascites.
Weight less than 40 kg.

History of congestive heart failure and/or an LVEF < 40%

Note: Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., > 65yo, diabetes, history of hypertension, elevated LDL, first degree relative with coronary artery disease) will undergo full cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on stress thallium or an ejection fraction < 40%. Patients may be eligible if cardiac status is treated and improves to within eligibility criteria.

Significant COPD or other chronic pulmonary restrictive disease with PFT's indicating an FEV1 less than 50% or a DLCO less than 40% predicted for age.

Note: Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing.

Discretion of principle investigator.