Actively Recruiting
Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases
Led by Cancer Research Antwerp · Updated on 2026-01-20
120
Participants Needed
8
Research Sites
208 weeks
Total Duration
On this page
Sponsors
C
Cancer Research Antwerp
Lead Sponsor
K
Kom Op Tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed solid tumor cancer with three or more metastases
- High-risk bone metastases that are asymptomatic or cause minimal symptoms (pain score 2 or less)
- At least one high-risk feature of bone metastases such as large size (2 cm or more), involvement of certain joints (hip, shoulder, sacroiliac), long bones with over one-third cortical involvement, or spine junctional areas with possible epidural extension
- Number of Risk Factors prognostic score between 0 and 2
- Age 18 years or older
- Ability to provide informed consent
- For females, not pregnant at screening and either not of childbearing potential or agreeing to use effective birth control
You will not qualify if you...
- Previous radiotherapy to the target treatment site(s)
- Number of Risk Factors prognostic score of 3
- Serious medical conditions that prevent radiotherapy
- Bone lesions with pathological or impending fractures needing stabilization (Mirels score 9 or higher)
- Spinal metastases with Spinal Instability Neoplastic Score greater than 13 requiring surgical stabilization
- More than 5 high-risk asymptomatic or minimally symptomatic bone metastases
- Participation in another clinical trial that would interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
ZAS Augustinus
Wilrijk, Antwerp, Belgium, 2610
Actively Recruiting
2
AZORG
Aalst, Belgium, 9300
Actively Recruiting
3
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
4
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Not Yet Recruiting
5
AZ Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
6
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Not Yet Recruiting
7
AZ Delta
Roeselare, Belgium, 8800
Actively Recruiting
8
AZ Turnhout
Turnhout, Belgium, 2300
Actively Recruiting
Research Team
C
Charlotte Billiet, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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