Comparing Radiation Therapy to Usual Treatment for Patients With High-Risk Bone Metastases That Are Not Causing Pain, PREEMPT Trial

Summary

This phase III trial compares the effect of adding radiation therapy to usual treatment on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms, such as pain (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual treatment for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual treatment may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.

Conditions

• Metastatic Malignant Neoplasm in the Bone
• Metastatic Malignant Solid Neoplasm

Interventions

OTHER

Best Practice

Given SOC systemic anti-cancer therapy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Bone Metastases Treatment

Given bone modifying agent

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Conventional Radiotherapy

Undergo conventional RT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Patient Observation

Undergo SOC observation

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Sponsors & Collaborators

• NRG Oncology

  lead OTHER

Principal Investigators

• Erin F Gillespie · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-07

Primary Completion

2029-02-01

Completion

2029-02-01

Countries

• United States
• Canada

Study Locations