A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms

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 of
being assigned to either group.

If you are in Group 1, you will receive 1 radiation treatment a day for 10 days in a row (not
counting weekends or holidays). You will receive a higher total dose of radiation than Group
2.

If you are in Group 2, you will receive 1 radiation treatment given on 1 day.

Radiation Therapy:

You will lie on a table for the radiation treatment(s). Each treatment will last about 30
minutes.

Length of Treatment:

You may receive 1 or 10 radiation treatments, depending on which group you are in. You will
no longer be able to receive radiation therapy if intolerable side effects occur or if you
are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

At Months 3, 6, 9, 12 and every 3 to 6 months after the start of radiation therapy, you will
have x-rays, a bone scan, CT scan, or MRI to check the status of the disease.

At Months 3, 4, and 6 and then every 3 months after that for at least 3 years, you will
complete the questionnaires about the pain, your pain relief, and your quality of life. The
questionnaires can be filled out at a clinic visit or sent back in the mail.

This is an investigational study. Radiation therapy is delivered using FDA-approved and
commercially available methods. It is investigational to compare the number and size of
radiation doses.

Up to 300 participants will take part in this multicenter study. Up to 300 participants will
be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with a pathologic diagnosis of malignancy

2. Patients with any radiographic evidence of bone metastases, including plain x-ray,
bone scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), or
positron emission tomography (PET) scan

3. Patients with pain or dysaesthesia

4. Patients with a life expectancy of more than 3 months

5. Patients able to complete pain assessment and quality of life surveys

6. Patients with multiple osseous sites are eligible; however should not treat more than
3 separate radiation treatment fields concurrently.

7. Patients with surgery for osseous metastases are allowed.

Exclusion Criteria:

1. Patients with prior radiation therapy to the treatment site

2. Patients with a current, untreated spinal cord compression

3. Patients with a radiographic or pathologic fracture to the treatment site

4. Patients with painful metastases to hands and feet that need to be radiated on
protocol

5. Patients previously treated with radioactive isotope (e.g. Sr89) within 30 days of
randomization