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Prophylactic Radiotherapy to Prevent Bone Complications in Metastatic Solid Cancers NCT07540650

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Summary

NIH registered a new prospective, randomized, single-center Phase 2 clinical trial (NCT07540650) to evaluate whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events in patients with metastatic solid cancers. Patients will be randomized 1:1 to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy plus standard of care. The primary endpoint is the 1-year rate of skeletal-related events; secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.

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What changed

NIH added a new Phase 2 clinical trial (NCT07540650) to the ClinicalTrials.gov registry. The trial enrolls patients with metastatic solid cancers and bone metastases, randomizing them 1:1 to standard of care or prophylactic external beam radiotherapy plus standard of care.

Healthcare providers, clinical investigators, and patients considering trial participation should review the eligibility criteria and randomization schedule. This registry entry does not create compliance obligations; it documents an ongoing research program.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers

Phase 2 NCT07540650 Kind: PHASE2 Apr 20, 2026

Abstract

This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.

Conditions: Bone Metastases, Metastatic Solid Tumor

Interventions: Prophylactic External Beam Radiotherapy, Standard of Care

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial participation Bone metastases research Oncology radiation therapy
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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