NCT07733193

Brief Summary

Radiation therapy is a common treatment for painful bone metastases, proving effective in 1 to 2/3 of cases after 1 to 10 sessions, with stereotactic body radiation therapy (SBRT) likely offering superior results. Radiation therapy is also used to prevent bone events, although its use is not standardized; the decision to administer it is made by clinicians or through multidisciplinary team (MDT) discussions. Recently, it has been shown that preventive radiation therapy can reduce the risk of skeletal-related events (SREs) in patients at high risk for bone events. The objective is to compare active surveillance with preventive radiation therapy in patients at intermediate risk for bone events.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P25-P50 for phase_3

Timeline
51mo left

Started Sep 2026

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 23, 2026

Last Update Submit

July 28, 2026

Conditions

Bone Metastases

Keywords

prophylactic radiationbone metastasespain

Outcome Measures

Primary Outcomes (1)

  • Bone event

    rate of bone event in the two arms

    one year

Study Arms (2)

Standard arm

ACTIVE COMPARATOR

no bone radiation for patient allocated in this arm

Drug: standard of care

Prophylactic radiation

EXPERIMENTAL

patient undergo prophylactic radiation on bone metastases

Radiation: prophylactic radiation

Interventions

prophylactic radiationRADIATION

Patients will undergo propthylactic radiation on bone metastases

Prophylactic radiation
standard of careDRUG

Patients will have systemic treatment on the standard of care

Standard arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women, 18 years of age or older
  • Patients with solid cancer and bone metastases
  • Patients with bone lesions considered to be at intermediate risk for skeletal-related events (SINS score between 7 and 12, Mirels 8) or patients with lesions accompanied by Grade 1 epiduritis (Bilsky)
  • Enrolled in or covered by a social insurance program
  • Patients with an estimated life expectancy of more than 6 months

You may not qualify if:

  • Hematologic disease
  • Patients with a lesion at high risk for skeletal-related events (SINS score of 13 or higher, MIRELS score of 9 or higher, or a multidisciplinary team (MDT) recommendation that surgery is necessary)
  • Patients with pain secondary to bone lesions requiring radiation therapy
  • Contraindication to radiation therapy due to a history of radiation therapy at the same site or a condition contraindicating radiation therapy
  • Pregnant or breastfeeding women
  • Contraindication to MRI in cases of spinal lesions; contrast-enhanced CT scan
  • Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographic issues, etc.)
  • Patients under legal guardianship or conservatorship
  • Patients classified as WHO 3 or 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de Cancérologie de Lorraine

Nancy, France

Location

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sebastien Thureau, MD, PhD

    Centre Henri Becquerel

    STUDY DIRECTOR

Central Study Contacts

Sebastien Thureau, MD, PhD

CONTACT

+0232082985sebastien.thureau@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985doriane.richard@chb.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 29, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

November 1, 2030

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)