Protocol Number: 04-C-0229
Patients 18 years of age and older with colorectal cancer that has spread to the liver may be eligible for this 2-year study. Patients whose tumor has spread to limited sites beyond the liver may also be considered eligible if the tumors outside the liver can be treated with surgery or radiation therapy. Patients must weigh at least 30 kilograms (66 pounds). Candidates are screened with a physical examination, chest x-ray, blood tests, electrocardiogram (EKG), CT scan of the chest, abdomen and pelvis, and MRI scan of the liver. Participants undergo laparotomy and isolated hepatic perfusion (IHP), as follows: - Laparotomy is a type of surgery done under general anesthesia through a small incision in the abdomen. It allows the surgeon to look at the amount and location of tumor in the abdomen. Sometimes tumors are found at laparotomy that were not detected by imaging tests such as CT and MRI. Patients who are found at laparotomy to have tumors that cannot be treated may not continue in the study. Patients who remain in the study proceed with IHP. - IHP is a major operation, done under general anesthesia. In this procedure, catheters (plastic tubes) are placed into the large blood vessels that deliver blood to and remove blood from the liver, creating a circulation to the liver separate from the rest of the body. During the operation, the liver receives oxygen from an external pump similar to the heart-lung machine used in open-heart surgery. For one hour, melphalan is administered through the pump in large doses that would not be safe if it reached all parts of the body in the normal blood circulation. The entire operation lasts between six and eight hours. If the patient's gallbladder has not been removed previously, it may be removed during the IHP. Other tumors found in the abdomen are also removed if they can easily be resected. Patients usually can be discharged from the hospital about 11-14 days after the surgery. Patients return to NIH 6 weeks after discharge for a checkup, x-rays, and blood tests and are then followed at the clinic every 3 to 4 months for x-rays and blood tests. Patients are also asked to complete quality of life questionnaires before surgery and at each clinic visit after surgery to evaluate the effect of the treatment on overall well being.
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