This phase 2 trial recruiting in Houston, Texas (US) aims to compare the effect of having a liver tumor surgically removed along with chemotherapy to chemotherapy alone in patients whose colorectal cancer has spread to their liver and lungs. The main outcome to be measured is overall survival (time from treatment until death from any cause) over 3 years.
The details
The liver and lungs are common areas affected by the spread of colorectal cancer. The standard treatment for patients with these metastases is chemotherapy. It is possible that having the liver tumors surgically removed may increase survival rates in these patients.
The current trial will examine whether combining chemotherapy with surgery is more effective than chemotherapy alone. The main outcome will be measured through rates of survival over a 3-year period.
Who are they looking for?
The trial will recruit 80 participants. Patients must have operable liver metastasis. Previous treatment with chemotherapy or biological agents is allowed. The colon or rectum tumor may be either intact or have been surgically removed. Participants must have a low number of inoperable lung tumors. Participants should not have metastasis in any other part of the body, inadequate liver function or be pregnant. Participants must not be planning on undergoing stereotactic body radiation therapy for the lung tumors.
How will it work
Patients will be randomly (as in the flip of a coin) assigned to one of two different groups. In group 1 patients will undergo liver surgery followed by chemotherapy. In group 2 patients will only receive chemotherapy.
Participants of both groups will have physical exams, chest, abdominal and pelvic checks (by x-ray, CT or MRI), blood tests and a survey about quality of life every 3 to 6 months. Participants will be followed for up to 3 years.
