NCT00003162

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

Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 949 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Metastatic Cancer
• Pain
• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	pain therapy
RADIATION	radiation therapy

Timeline

• Start date: 1998-02-01
• Primary completion: 2003-07-01
• First posted: 2003-04-18
• Last updated: 2015-11-17

Locations

253 sites across 2 countries: United States, Canada