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

NCT06065449 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-01-14

No results posted yet for this study

Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Quynh Nguyen, M D · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2027-06-27
Completion
2027-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065449 on ClinicalTrials.gov