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Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer

2014-07-23 21:57:04 | BioPortfolio

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Supportive Care

Conditions

Breast Cancer

Intervention

pain therapy, radiation therapy

Location

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham
Alabama
United States
35294-3300

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:57:04-0400

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