Actively Recruiting
Phase III Randomized Trial Comparing 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
N/A
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
Researchers are investigating whether preventive radiotherapy can reduce symptoms and complications in patients with metastatic cancer who have high-risk bone metastases that cause no or minimal symptoms. This study focuses on determining if early radiation treatment, in addition to standard medication or observation, can lower the number of skeletal-related events, reduce hospitalizations, improve survival, and enhance quality of life. The study is a multi-center, randomized phase 3 trial involving patients with various solid tumors prone to bone metastases. Participants will be randomly assigned to one of two groups: one receiving standard systemic therapy or observation alone, and the other receiving preventive radiotherapy plus standard therapy or observation. Radiotherapy may be a single dose or stereotactic ablative body radiation delivered within 21 days after randomization. During follow-up, patients in the radiotherapy group may receive additional preventative radiation for new high-risk bone metastases, with up to five lesions treated at once. Participants will undergo screening to confirm eligibility, including assessments of medical history, quality of life, and pain for each bone lesion. Follow-up visits will occur at 1, 3, 6, 12, 18, and 24 months after randomization to monitor safety, efficacy, side effects, medication use, pain, and quality of life through questionnaires. In case of skeletal-related events, assessments will be done promptly, and survival and hospitalization data will continue to be recorded until 24 months post-randomization.
CONDITIONS
Brief 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 with three or more metastatic sites
- High-risk bone metastases that are asymptomatic or have mild pain (pain score 2 or less)
- At least one high-risk feature such as bulky bone disease (2 cm or larger), involvement of hip, shoulder or sacroiliac joints, long bones with significant cortical involvement, or certain spine locations
- Number of Risk Factors (NRF) prognostic score between 0 and 2
- Age 18 years or older
- Ability to provide informed consent
- Female participants must confirm they are not pregnant and agree to use effective birth control if of childbearing potential
You will not qualify if you...
- Previous radiation therapy to the target bone lesion(s)
- NRF prognostic score of 3
- Serious medical conditions preventing radiotherapy
- Bone lesions complicated by pathological fracture or high risk of fracture needing stabilization
- Spinal metastases requiring neurosurgical stabilization
- More than five high-risk asymptomatic or minimally symptomatic bone metastases
- Participation in another clinical trial that would interfere with this study as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiotherapy within 21 days after randomization; systemic therapy or observation ongoing as per standard care
Participants are randomized to receive either preventive radiotherapy plus systemic therapy or observation, or systemic therapy/observation alone according to standard care.
Radiotherapy occurs once within 21 days after randomization for those assigned; ongoing systemic therapy or observation as per standard care
Duration - 24 months after randomization
Participants have scheduled visits to monitor safety, efficacy, and quality of life for up to 24 months after randomization. Additional preventive radiotherapy may be given if new high-risk bone metastases develop in the radiotherapy arm.
6 visits at 1, 3, 6, 12, 18, and 24 months after randomization
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
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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