Solid NeoplasmsHERMESNCT07146074
Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases
A study testing Preventive radiotherapy in people with Solid Neoplasms and Bone Metastases, run by Cancer Research Antwerp at 8 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Neoplasms, Bone Metastases, Asymptomatic or Minimally Symptomatic
- What is being tested?
- Preventive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesBelgium
- Study dates
- 5 Feb 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases))
- I2: High-risk bone metastasis(es) that is (are) asymptomatic or minimally symptomatic:
- Asymptomatic or minimally symptomatic is defined as follows: O Numeric Pain Rating Scale (NRS) score ≤2 for the specific lesion(s)
- High-risk is defined as follows (i.e. at least one of the following points must be applicable): O Bulky site of disease in bone (diameter ≥ 2 cm) O Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints O Disease in long bones with cortical involvement of >1/3 in proportion to the diameter of the bone (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges) O Disease in vertebrae of the junctional spine (C1-2, C7- T1, T12-L1, L5-S1) and/or disease with posterior element involvement or epidural extension (Bilsky epidural compression score 1a-3) [Bilsky et al]. The posterior elements of the spine consist of the pedicles, laminae, facets (articular processes), transverse processes, and the spinous process.
- I3: Number of Risk Factors (NRF) prognostic score 0-2
- I4: Age ≥ 18 years
Show all 9Show fewer
- I5: Ability to provide informed consent (either by the patient or by a legally authorized representative)
- I6: A female participant is eligible to participate if she confirms not to be pregnant at screening, and one of the following conditions applies:
- Is not a woman of child bearing potential or A woman of child bearing potential must confirm that she is not pregnant at screening and must agree to use a very effective method of birth control
Who cannot join
- E1: Previous RT to the target treatment site(s)
- E2: NRF prognostic score 3
- E3: Serious medical co-morbidities that preclude radiotherapy
- E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended, characterized by Mirels score of ≥9 [Mirels et al].
- E5: Spinal metastasis with SINS score >13 requiring upfront neurosurgical stabilization [Fourney et al].
- E6: More than 5 high-risk asymptomatic or minimally symptomatic metastatic bone locations
- E7: Patient already included in another clinical trial that would interfere with the HERMES clinical trial, as assessed by the Investigator.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Belgium8 sites, 8 recruiting
- Recruiting
AZORG
Aalst, 9300
Samuel Bral
Samuel Bral
- Recruiting
UZ Gent
Ghent, 9000
Yolande Lievens
Yolande Lievens
- Not yet recruiting
Jessa Ziekenhuis
Hasselt, 3500
Katleen Verboven
Katleen Verboven
- Recruiting
AZ Groeninge
Kortrijk, 8500
Nora Sundahl
Nora Sundahl
- Not yet recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
Eva Oldenburger
Eva Oldenburger
- Recruiting
AZ Delta
Roeselare, 8800
Caroline Sweldens
Caroline Sweldens
- Recruiting
AZ Turnhout
Turnhout, 2300
Stéphanie Smet
Stéphanie Smet
- Recruiting
ZAS Augustinus
Wilrijk, Antwerp, 2610
Charlotte Billiet, MD, PhD, 03/443.37.59, Cancertrials@zas.be
Charlotte Billiet, MD, PhD
About this study
Official title: Phase III Randomized Trial for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases: Early Radiotherapy Versus Observation
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:
Read more
- 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.
Read the detailed description
It is estimated that two out of three patients with advanced cancer will develop metastases in the bones (i.e. bone metastases). Any type of cancer can spread to the bone, but the types of cancer in which the likelihood of spreading to the bone is greatest include prostate cancer, breast cancer, lung cancer, kidney cancer and skin cancer. The development of bone metastases is a serious complication of cancer that greatly affect quality of life. A large proportion of patients experience bone pain and associated reduced mobility. Bone metastases can also cause bone fractures. The growth of bone metastases in the vertebrae can lead to entrapment of the spinal cord. This is called spinal cord compression. The symptoms can range from mild (pain and a tingling sensation) to very severe (paralysis). In the English-language literature, these bone complications due to bone metastases are often indicated as skeletal-related events ("skeletal-related events"; SREs) or symptomatic skeletal-related events ("symptomatic skeletal-related events"; SSEs) when they also cause symptoms.
SSEs are defined as:
- symptomatic pathological fracture
- spinal cord compression leading to neurological deficit or pain
- Indication for palliative radiotherapy (for bone pain, cord compression or (impending) fracture)
- Indication for orthopedic surgery (for bone pain, cord compression or (impending) fracture)
When SSE occur that have a negative impact on the quality of life, these can be treated with systemic therapy, surgery or radiotherapy (RT). Scientific evidence is already available for radiotherapy as an effective treatment for patients with bone metastases causing symptoms. Recent data from an American trial suggest that also preventive radiotherapy of high-risk asymptomatic bone metastases may have a favorable effect. Hence, the aim of the HERMES study is to investigate if early preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases in patients with metastatic cancer can decrease the number of symptomatic skeletal events (SSEs) in a multi-centric randomized phase 3 trial.
A potential participant needs to sign an informed consent form before participating in the HERMES study. Participation in the HERMES study will comprise a screening period, during which the screening assessments must be completed, a treatment phase and a follow-up phase.
During the screening phase, eligibility of the patient to participate in the study will be assessed. Demographics data, Karnofsky performance score, information regarding medical history, prior medications and adverse events will be recorded. Moreover, the potential participant needs to complete questionnaires regarding his/her quality of life, characteristics of the high-risk metastases will be recorded based on imaging and a pain score will be determined for each lesion.
Eligible, consenting subjects will then be randomized (1:1) into one of two treatment arms: an observational arm (arm A) receiving systemic therapy / observation or an upfront RT arm (arm B) receiving upfront RT plus systemic therapy / observation.
During the treatment phase, RT should take place within 21 days after date of randomization for subjects in arm B. Participants of both study arms receive either systemic therapy or observation, according to the standard of care guidelines.
The follow-up phase consists of 6 follow-up visits which will take place at 1, 3, 6, 12, 18 and 24 months after date of randomization and during which safety and efficacy are monitored. More specifically, the Karnofsky performance score, concomitant medications and adverse events will be recorded at each visit. Moreover, the potential participant needs to complete questionnaires regarding his/her quality of life. Note that patients in arm B are strongly advised to receive additional preventive radiotherapy in case of appearance of new asymptomatic or minimally symptomatic high-risk bone metastases during follow-up. A maximum of 5 high-risk asymptomatic or minimally symptomatic bone metastases can be irradiated at once.
In case an SSE would occur, the assessments that should take place during the next follow-up visit, should be completed at that time point, preferably within one week. Afterwards, only survival data will be recorded on the planned FU visits until 24 months after the randomization date as well as possible occurrence of another SSE and hospitalizations related to the high-risk bone metastasis(es) until 24 months after the randomization date.
- Conditions
- Solid Neoplasms, Bone Metastases, Asymptomatic or Minimally Symptomatic, High Risk for Skeletal Events
- Being tested
- Preventive radiotherapy, Systemic therapy (Standard of Care)/Observation
- Keywords
- Bone metastases, Randomized, Radiotherapy, Symptomatic skeletal events, Preventive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive radiotherapyRadiation
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.
Systemic therapy (Standard of Care)/ObservationDrug
It concerns systemic therapy if applicable according to the standard of care or only observation.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: observational arm | Active comparator | Patients in arm A will receive either systemic therapy or observation. Receives: Drug: Systemic therapy (Standard of Care)/Observation |
| Arm B: upfront radiotherapy arm | Experimental | Patients in arm B will receive preventive (upfront) radiotherapy in addition to either systemic therapy or observation. Receives: Radiation: Preventive radiotherapy; Drug: Systemic therapy (Standard of Care)/Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to a symptomatic skeletal related event (SSE) in any bone metastasis or death due to any cause whichever occurs first
Time to an SSE in any bone metastasis or death due to any cause whichever occurs first. An exception are SSE in bone metastases that were already treated with surgery or radiotherapy before study participation.
Measured: Measured from the date of randomization to the date when an SSE occurs in any bone metastasis, date of death due to any cause or last follow-up visit at 24 months after randomization whichever occurs first.
Secondary outcomes (7)
Need for hospitalization related to the high-risk bone metastasis(es).
The number of hospitalizations related to the high-risk bone metastases will be compared between arm A (systemic therapy/observation) and arm B (systemic therapy/observation + upfront radiotherapy).
Measured: Measured from date of study randomization to last follow-up visit (24 months after randomization date), date of death of any cause or early end of participation in the study due to other reasons whichever occurs first.
Overall survival (OS)
Overall survival
Measured: Measured from time of study randomization to date of death of any cause or last follow-up visit (24 months after randomization date) whichever occurs first
Quality of life (QoL) measurement by EORTC QLQ-C15-PAL questionnaire (physical and emotional function, dyspnoea, pain, sleeping difficulties, appetite, nausea/vomiting, constipation, fatigue)
Changes in the scores regarding physical and emotional function, dyspnoea, pain, sleeping difficulties, appetite, nausea/vomiting, constipation and fatigue over time compared to baseline as well as absolute scores will be compared between both treatment arms. The scale ranges from 1 up to 4 with a higher score representing a worse outcome.
Measured: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Quality of life (QoL) measurement by EORTC QLQ-C15-PAL questionnaire (overall quality of life)
Changes in the scores, representing the participant's overall quality of life, over time compared to baseline as well as absolute scores will be compared between both treatment arms. The scale ranges from 1 up to 7 with a higher score representing a better outcome.
Measured: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Quality of life measurement by EuroQol Group EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Changes in the scores, regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression, over time compared to baseline as well as absolute scores will be compared between both treatment arms.
Measured: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Quality of life measurement by EuroQol Group EQ-5D-5L questionnaire (health "today").
Changes in the scores regarding health "today" over time compared to baseline as well as absolute scores will be compared between both treatment arms. The scale ranges from 0 up to 100 with a higher score representing a better outcome.
Measured: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Acute and late toxicity
Adverse events in both study arms will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 . Only adverse events that are related to the bone metastatic disease or related to the radiotherapy (only for patients in arm B) will be reported in the context of the HERMES study.
Measured: From time of ICF signing to last follow-up visit (24 months after randomization date), visit 1 week after occurrence of an SSE, date of death of any cause or early end of participation in the study due to other reason whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start5 Feb 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Charlotte Billiet, MD, PhD, Principal investigator, Ziekenhuis aan de Stroom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146074
- Sponsor's protocol ID
- CTO23032GZA
- Acronym
- HERMES
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases: Early Radiotherapy Versus Observation
- ClinicalTrials.gov ID
- NCT07146074
- Acronym / sponsor ID
- HERMES / CTO23032GZA
- Conditions
- Solid Neoplasms, Bone Metastases, Asymptomatic or Minimally Symptomatic, High Risk for Skeletal Events
- Keywords
- Bone metastases, Randomized, Radiotherapy, Symptomatic skeletal events, Preventive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cancer Research AntwerpUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is estimated that two out of three patients with advanced cancer will develop metastases in the bones (i.e. bone metastases). Any type of cancer can spread to the bone, but the types of cancer in which the likelihood of spreading to the bone is greatest include prostate cancer, breast cancer, lung cancer, kidney cancer and skin cancer. The development of bone metastases is a serious complication of cancer that greatly affect quality of life. A large proportion of patients experience bone pain and associated reduced mobility. Bone metastases can also cause bone fractures. The growth of bone metastases in the vertebrae can lead to entrapment of the spinal cord. This is called spinal cord compression. The symptoms can range from mild (pain and a tingling sensation) to very severe (paralysis). In the English-language literature, these bone complications due to bone metastases are often indicated as skeletal-related events ("skeletal-related events"; SREs) or symptomatic skeletal-related events ("symptomatic skeletal-related events"; SSEs) when they also cause symptoms.
SSEs are defined as:
- symptomatic pathological fracture
- spinal cord compression leading to neurological deficit or pain
- Indication for palliative radiotherapy (for bone pain, cord compression or (impending) fracture)
- Indication for orthopedic surgery (for bone pain, cord compression or (impending) fracture)
When SSE occur that have a negative impact on the quality of life, these can be treated with systemic therapy, surgery or radiotherapy (RT). Scientific evidence is already available for radiotherapy as an effective treatment for patients with bone metastases causing symptoms. Recent data from an American trial suggest that also preventive radiotherapy of high-risk asymptomatic bone metastases may have a favorable effect. Hence, the aim of the HERMES study is to investigate if early preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases in patients with metastatic cancer can decrease the number of symptomatic skeletal events (SSEs) in a multi-centric randomized phase 3 trial.
A potential participant needs to sign an informed consent form before participating in the HERMES study. Participation in the HERMES study will comprise a screening period, during which the screening assessments must be completed, a treatment phase and a follow-up phase.
During the screening phase, eligibility of the patient to participate in the study will be assessed. Demographics data, Karnofsky performance score, information regarding medical history, prior medications and adverse events will be recorded. Moreover, the potential participant needs to complete questionnaires regarding his/her quality of life, characteristics of the high-risk metastases will be recorded based on imaging and a pain score will be determined for each lesion.
Eligible, consenting subjects will then be randomized (1:1) into one of two treatment arms: an observational arm (arm A) receiving systemic therapy / observation or an upfront RT arm (arm B) receiving upfront RT plus systemic therapy / observation.
During the treatment phase, RT should take place within 21 days after date of randomization for subjects in arm B. Participants of both study arms receive either systemic therapy or observation, according to the standard of care guidelines.
The follow-up phase consists of 6 follow-up visits which will take place at 1, 3, 6, 12, 18 and 24 months after date of randomization and during which safety and efficacy are monitored. More specifically, the Karnofsky performance score, concomitant medications and adverse events will be recorded at each visit. Moreover, the potential participant needs to complete questionnaires regarding his/her quality of life. Note that patients in arm B are strongly advised to receive additional preventive radiotherapy in case of appearance of new asymptomatic or minimally symptomatic high-risk bone metastases during follow-up. A maximum of 5 high-risk asymptomatic or minimally symptomatic bone metastases can be irradiated at once.
In case an SSE would occur, the assessments that should take place during the next follow-up visit, should be completed at that time point, preferably within one week. Afterwards, only survival data will be recorded on the planned FU visits until 24 months after the randomization date as well as possible occurrence of another SSE and hospitalizations related to the high-risk bone metastasis(es) until 24 months after the randomization date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: observational arm | Active comparator | Drug: Systemic therapy (Standard of Care)/ObservationPatients in arm A will receive either systemic therapy or observation. |
| Arm B: upfront radiotherapy arm | Experimental | Radiation: Preventive radiotherapy, Drug: Systemic therapy (Standard of Care)/ObservationPatients in arm B will receive preventive (upfront) radiotherapy in addition to either systemic therapy or observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases))
- I2: High-risk bone metastasis(es) that is (are) asymptomatic or minimally symptomatic:
- Asymptomatic or minimally symptomatic is defined as follows: O Numeric Pain Rating Scale (NRS) score ≤2 for the specific lesion(s)
- High-risk is defined as follows (i.e. at least one of the following points must be applicable): O Bulky site of disease in bone (diameter ≥ 2 cm) O Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints O Disease in long bones with cortical involvement of >1/3 in proportion to the diameter of the bone (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges) O Disease in vertebrae of the junctional spine (C1-2, C7- T1, T12-L1, L5-S1) and/or disease with posterior element involvement or epidural extension (Bilsky epidural compression score 1a-3) [Bilsky et al]. The posterior elements of the spine consist of the pedicles, laminae, facets (articular processes), transverse processes, and the spinous process.
- I3: Number of Risk Factors (NRF) prognostic score 0-2
Key exclusion criteria (7 listed)
- E1: Previous RT to the target treatment site(s)
- E2: NRF prognostic score 3
- E3: Serious medical co-morbidities that preclude radiotherapy
- E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended, characterized by Mirels score of ≥9 [Mirels et al].
- E5: Spinal metastasis with SINS score >13 requiring upfront neurosurgical stabilization [Fourney et al].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive radiotherapyEither 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. | Radiation | Arm B: upfront radiotherapy arm |
| Systemic therapy (Standard of Care)/ObservationIt concerns systemic therapy if applicable according to the standard of care or only observation. | Drug | Arm A: observational arm, Arm B: upfront radiotherapy arm |
Primary outcome
Time to a symptomatic skeletal related event (SSE) in any bone metastasis or death due to any cause whichever occurs first
Time frame: Measured from the date of randomization to the date when an SSE occurs in any bone metastasis, date of death due to any cause or last follow-up visit at 24 months after randomization whichever occurs first.
Time to an SSE in any bone metastasis or death due to any cause whichever occurs first. An exception are SSE in bone metastases that were already treated with surgery or radiotherapy before study participation.
7 secondary outcomes
Need for hospitalization related to the high-risk bone metastasis(es).
Time frame: Measured from date of study randomization to last follow-up visit (24 months after randomization date), date of death of any cause or early end of participation in the study due to other reasons whichever occurs first.
Overall survival (OS)
Time frame: Measured from time of study randomization to date of death of any cause or last follow-up visit (24 months after randomization date) whichever occurs first
Quality of life (QoL) measurement by EORTC QLQ-C15-PAL questionnaire (physical and emotional function, dyspnoea, pain, sleeping difficulties, appetite, nausea/vomiting, constipation, fatigue)
Time frame: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Quality of life (QoL) measurement by EORTC QLQ-C15-PAL questionnaire (overall quality of life)
Time frame: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Quality of life measurement by EuroQol Group EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Time frame: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Quality of life measurement by EuroQol Group EQ-5D-5L questionnaire (health "today").
Time frame: From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
Acute and late toxicity
Time frame: From time of ICF signing to last follow-up visit (24 months after randomization date), visit 1 week after occurrence of an SSE, date of death of any cause or early end of participation in the study due to other reason whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Billiet, MD, PhD principal investigator
Ziekenhuis aan de Stroom
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive radiotherapy in people with Solid Neoplasms and Bone Metastases, run by Cancer Research Antwerp at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Billiet, MD, PhD (034433759, cancertrials@zas.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to a symptomatic skeletal related event (SSE) in any bone metastasis or death due to any cause whichever occurs first (time frame: Measured from the date of randomization to the date when an SSE occurs in any bone metastasis, date of death due to any cause or last follow-up visit at 24 months after randomization whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.