Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

PRIMARY OBJECTIVES:

I. To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates
compared to 8 Gy x 1 fraction.

SECONDARY OBJECTIVES:

I. To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief
compared to 8 Gy x 1 fraction.

II. To determine whether 8 Gy x 2 fractions is associated with improved quality of life
compared to 8 Gy x 1 fraction.

III. To determine whether use of a bone strengthening agent is associated with improved pain
relief, narcotic relief and re-treatment rates.

IV. To determine if 8 Gy x 2 fractions is associated with increased toxicity. V. To correlate
patient satisfaction, perceived stress, and social support with treatment outcomes.

TERTIARY OBJECTIVES:

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo 1 fraction of external beam radiation therapy (EBRT) over 30 minutes.

ARM II: Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be
separated by 3-7 days.

After completion of study treatment, patients are followed up at 30 days and at 3 months.

Inclusion Criteria:

- Diagnosis of cancer, not including multiple myeloma

- Radiographic evidence of bone metastases within 8 weeks of study; the patient must
have pain which appears to be related to the radiographically documented metastasis in
the opinion of the treating physician, and the decision has been made by the
responsible clinician that a course of palliative external beam radiation therapy is
appropriate treatment; multiple sites eligible if they can be included in no greater
than 3 treatment sites

- Eligible treatment sites are:

- Weight bearing sites

- Pelvis (excluding pubis)

- Femur

- Sacrum and/or sacroiliac joints

- Tibia

- Non-weight bearing sites

- Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies

- Lumbosacral spine

- Up to 3 consecutive ribs

- Humerus

- Fibula

- Radius ± ulna

- Clavicle

- Sternum

- Scapula

- Pubis If multiple sites are treated, the treatment site is included as
weight-bearing if any of the sites include the pelvis, sacrum, femur or
tibia

- Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain
score < 5 with >= 60 mg of morphine (or equivalent) per day

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3

- Ability to understand and the willingness to sign an Institutional Review Board
(IRB)-approved informed consent document

- Negative pregnancy test at study registration

- Changes in systemic chemotherapy, hormonal therapy or the use of bisphosphonates for 4
weeks before and after the delivery of radiotherapy are allowed, but recording and
accounting for this in the statistical analysis is required

- Life expectancy of at least 12 weeks as deemed by the treating oncologist

- Patients will be eligible for treatment of multiple osseous sites only if those sites
can be included in no more than three treatment sites; for patients with painful
metastases that are contiguous but do not fit into the definition of a site listed
above, those patients will still be eligible but will be considered to have two
treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be
eligible but would be considered as two treatment sites since more than five
consecutive vertebral bodies would be treated; these lesions could be treated with one
field, even though the treatment is coded as two sites

Exclusion Criteria:

- Previous radiotherapy or palliative surgery to the painful site

- Metastases to the skull, hands, feet are not eligible treatment sites

- Spinal cord or cauda equine compression/effacement in vertebral metastases with
neurological symptoms other than just pain