Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer (Liver Resection With Unresectable Lung Nodules From Colorectal Adenocarcinoma - LUNA)

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study
group is better, the same, or worse than the other group. You will have an equal chance to be
assigned to either group.

- If you are assigned to Group 1, you will have liver resection surgery, followed by
standard of care chemotherapy. The chemotherapy you receive will depend on what the
doctor thinks is in your best interest.

- If you are assigned to Group 2, you will receive standard of care chemotherapy that your
doctor thinks is in your best interest.

You will sign a separate consent form explaining how the standard of care chemotherapy works,
the chemotherapy schedule, and its risks.

Group 1:

If you are in Group 1, you will have standard of care liver resection surgery. A portion of
the liver that is affected by the tumor will be removed either with many small incisions or
one large incision. An ultrasound device will be used to help the doctor see the affected
area. The study doctor will explain this procedure in more detail and you will sign a
separate consent form explaining the standard of care surgery and its risks.

Study Visits:

Both groups will have study visits every 3-6 months while on study. The following tests and
procedures will be performed:

- You will have a physical exam.

- You will have a chest x-ray or CT scan to check status of disease.

- You will have an abdominal and pelvic CT scan, PET/CT scan, or an MRI scan to check the
status of the disease.

- Blood (about 2 teaspoons) will be drawn for biomarker testing.

- You will complete the quality of life survey you completed during screening.

If you are unable to return to MD Anderson every 3-6 months, you or your regular care doctor
will be contacted for follow-up information, and the tests listed above can be performed
outside of MD Anderson. The study doctor will discuss this with you.

Length of Study:

You will be on study for up to 3 years. You will be taken off study if the disease gets worse
or intolerable side effects occur.

Inclusion Criteria:

1. Patients with synchronous or metachronous diagnosis of resectable liver metastases by
computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen: a)
Patients requiring percutaneous or intraoperative ablation of liver metastases < 2 cm
in size are eligible. b) Patients who underwent prior liver resection or ablation for
colorectal liver metastases are eligible.

2. Patients previously treated with systemic chemotherapy and/or biologic agents for
colorectal cancer are eligible.

3. The primary tumor in the colon or rectum may be intact or resected.

4. Low-volume lung metastases are defined as solid pulmonary nodules < 2 cm with
non-spiculated contours, no benign-appearing calcifications, and diagnosed by computed tomography of the chest or positron emission tomography (PET).

5. Lung metastases will be unresectable due to anatomic location, distribution, or
patients' comorbidities, as determined by review of imaging by a faculty member in the
Department of Thoracic & Cardiovascular Surgery.

6. Patients 18 years of age and older.

7. Patients must sign a study-specific consent form.

8. Patients will undergo CT imaging of the chest, abdomen, and pelvis to evaluate lung
and liver metastases within 30 days of registration. For patients who cannot tolerate
CT contrast or have hepatic steatosis that reduces the sensitivity of CT, MRI of the
liver will be performed.

Exclusion Criteria:

1. Radiographic evidence of disease other than liver and lungs, with the exception of
mediastinal lymph nodes < 2 cm and hepatoduodenal ligament lymphadenopathy, diagnosed
by computed tomography, magnetic resonance imaging, or positron emission tomography.

2. Inadequate liver function, as evidenced by serum bilirubin >/= 2 mg/dL, international
normalized ratio (INR) >/= 1.7, and/or platelet count < 50,000/microL.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 3-4.

4. Patient refusal to participate in randomization.

5. Pregnant women are excluded from this study.

6. Planned stereotactic body radiation therapy (SBRT) for the pulmonary metastases.