Metastasectomy Study in Renal Cell Carcinoma (RCC)

This research study is designed to follow your progress after the surgery is complete. You
will not receive any drugs or treatment as part of this research study. You may however
receive non-study treatment after your surgery.

Study Visits:

Every 6 months for 5 years after surgery, the following tests and procedures will be
performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 2-3 teaspoons) and urine will be collected for routine tests.

- You will have CT scans or MRI scans of your chest, stomach area, and brain to check the
status of the disease.

- If the study doctor thinks it is necessary, you will have a bone scan to check the
status of the disease.

Length of Study:

You will have study visits for up to 5 years after the surgery is complete. You will be taken
off study early if the disease gets worse, or if the study doctor thinks that it is no longer
in your best interest to continue.

Long-Term Follow-Up:

About every 6 months after your last study visit, the study staff will either review your
medical records or contact you by phone or email to collect information about your health, to
see how you are doing, and what anti-cancer treatments you may have received. If you are
contacted by phone, the call should only last about 5 minutes each time.

This is an investigational study. Up to 120 patients will take part in this study. All will
be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed renal cell carcinoma (RCC).

2. 2. Patients have clinical reasons for undergoing a surgical resection of tumor. There
are two main categories of patients: a)Patients with fully resectable disease as
defined by lesions accessible by a surgeon during no more than two separate surgical
sessions, and are expected to be rendered surgically no evidence of disease (NED). b)
Patients undergoing a noncurative procedure for relief of symptoms or for management
of threatening lesions.

3. Patients have been deemed resectable by the subspecialty surgeon involved in the
patient's care

4. Patients must give written informed consent prior to initiation of therapy, in keeping
with the policies of the institution. Patients with a history of major psychiatric
illness must be judged able to fully understand the investigational nature of the
study and the risks associated with the therapy. The only approved consent is attached
to this protocol

5. Patients must have ability to comply with study and/or follow-up procedures.

6. Both men and women and members of all races and ethnic groups are eligible for this
trial.

Exclusion Criteria:

1. Patients must not have active acute infections that could be worsened by surgery or
interfere with this study.

2. Patients must not have clinically significant cardiovascular disease, or peripheral
vascular disease that creates an unacceptably high operative risk.

3. Patients must not have history of other diseases, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates surgical resection, or render the subject at
high risk from treatment complications.

4. Patients must not have a history of uncontrolled severe depression.