NCT06065449

A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.

Detailed description

Primary Objectives: • Pain response will be assessed at 2 weeks, 1 month, 3 months and then every 3 months post-treatment and will be determined based on International Pain Consensus Criteria between the two treatment arms. The 3-month pain response will be used as the primary endpoint in trial design and for powering the test of the study's primary hypothesis of pain response. Secondary Objectives: * The local failure rate will be determined by radiographic response after radiation therapy. If the radiographic reports are indeterminate, the local failure rate will be based on second consecutive radiographic report showing local progression. * To evaluate narcotics utilization converted to OMED (oral Morphine Equivalent Dose) compared to baseline prior to radiotherapy in both treatment arms. * To evaluate rate of re-irradiation in both treatment arms. * To evaluate rate of pathologic fracture in both treatment arms. * To report overall survival, time from end of radiation treatment to date of death from any cause. * To report both acute and long-term toxicity associated with radiotherapy in both treatment arms. * To report of rate of salvage surgery after radiotherapy in both treatment arms. * To report quality of life outcome measures defined in PROMIS study

Conditions

• Bone Metastases

Interventions

Type	Name	Description
DRUG	Radiation Therapy	Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV).

Timeline

• Start date: 2024-01-24
• Primary completion: 2027-06-27
• Completion: 2027-06-27
• First posted: 2023-10-04
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study