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Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases

NCT07146074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-20

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether radiotherapy (i.e. treatment with ionizing radiation to destroy cancer cells) can prevent symptoms in patients with metastatic cancer, having high-risk bone metastases that currently result in no or only mild symptoms. High-risk bone metastases are bone metastases at high-risk of developing bone complications, such as fractures or myelum compression.

The main questions this study aims to answer are:

* Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the number of skeletal related events (i.e. bone complications due to bone metastases) in patients with metastatic cancer?
* Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the need for hospitalization related to such bone metastases, improve overall survival and (health-related) quality of life?
* What are the side effects of preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases?

Researchers will compare 2 treatment groups in order to answer the questions listed above: 1 group treated with medication or observation alone (group A) and 1 group treated with medication or observation and preventive radiotherapy (group B).

Participants will

* be screened to assess whether they are eligible to participate in the study.
* be randomized (i.e. drawn) into the 2 treatment groups mentioned above.
* be treated with preventive radiotherapy if they were drawn in treatment group B.
* need to attend follow-up visits (may be via teleconsultation) at 1, 3, 6, 12, 18 and 24 months after date of randomization during which safety and efficacy is monitored. During these follow-up visits, the general health condition of the participant is evaluated, the occurrence of any bone complication, the medications taken by the participant are registered, the degree of pain and location of the high-risk bone metastases are determined and possible side effects are registered. Furthermore, the participant needs to complete 2 questionnaires at each visit regarding his/her quality of life.

Conditions

  • Solid Neoplasms
  • Bone Metastases
  • Asymptomatic or Minimally Symptomatic
  • High Risk for Skeletal Events

Interventions

RADIATION

Preventive radiotherapy

Either conventional radiotherapy (single dose of 8 Gy) or Stereotactic Ablative Body Radiation (either 1x20 Gy, 2x12 Gy, 3x10 Gy or 5x8 Gy) will be delivered depending on the participant's prognostic outcome.

DRUG

Systemic therapy (Standard of Care)/Observation

It concerns systemic therapy if applicable according to the standard of care or only observation.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Cancer Research Antwerp

    lead OTHER

Principal Investigators

  • Charlotte Billiet, MD, PhD · Ziekenhuis aan de Stroom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT07146074 on ClinicalTrials.gov