Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective for bone metastases.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer.

Further Study Information

OBJECTIVES:

• Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer.

• Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations.

• Compare the effect on quality of life of these two treatments in these patient populations.

• Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations.

OUTLINE: This is a randomized study.

Patients are assigned to 1 of 2 treatment arms. Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks. Arm II consists of a single dose of radiation therapy. Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score.

Patients are followed and quality of life is assessed at 2 and 4 weeks, then at 2, 3, 6, 9, and 12 months, every 6 months for the next 3 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue 938 patients within 2 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically proven breast or prostate cancer

• Radiographic evidence of bone metastasis within 8 weeks of study

• Eligible treatment sites:

• Weight bearing sites:

• Pelvis (excluding pubis)

• Femur

• Sacrum and/or sacroiliac joints

• Tibia

• Nonweight bearing sites:

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

• Lumbosacral spine

• Up to 3 consecutive ribs

• Humerus

• Fibula

• Radius with/without ulna

• Clavicle

• Scapula

• Pubis

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

• Worst pain score of at least 5 on a scale of 10

• No skull, feet, or hand metastases

• No spinal cord or cauda equina compression/effacement in vertebral metastases

• Multiple sites eligible if they can be included in no greater than 3 treatment sites

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 40-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No impending fracture of the treatment site

• No hematologic primary malignancies

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No change in immunotherapy within 30 days

Chemotherapy:

• No change in chemotherapy within 30 days

Endocrine therapy:

• No change in hormonal therapy within 30 days

Radiotherapy:

• No prior radiation therapy to treatment area

• At least 30 days since systemic radiotherapy (Sr 89)

Surgery:

• No prior palliative surgery to treatment area

• No planned surgical fixation of the bone

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

William F. Hartsell

Study Chair

Ivy A. Petersen

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003162
Information obtained from ClinicalTrials.gov on November 20, 2012

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