NCT02699697

Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

A Prospective Randomized Phase II Study of 1 vs 2 Fractions of Palliative Radiation Therapy for Patients With Symptomatic Bone Metastasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis). Palliative radiation therapy using external beam radiation therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by cancer.

Detailed description

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.

Conditions

• Malignant Neoplasm
• Metastatic Malignant Neoplasm in the Bone
• Pain

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo EBRT
RADIATION	Palliative Radiation Therapy	Undergo EBRT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-05-01
• Primary completion: 2025-03-20
• Completion: 2025-03-20
• First posted: 2016-03-04
• Last updated: 2025-12-11
• Results posted: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study