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Oligometastatic DiseaseNCT05101824

Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease

A study testing SABR in people with Oligometastatic Disease and Bone Metastases, run by Gitte Fredberg Persson MD PhD at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, investigator-initiated, phase II, multicentre-study, investigating the efficacy and toxicity of definitive SABR of osseous oligometastases, when pragmatically introduced into a daily clinical setting. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SABR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
6 sitesin 2 countries
Study dates
1 Nov 2019to 1 Nov 2027
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

  • Histology or cytology proven non-haematological cancer.
  • At least one lesion in the bones is required.
  • ECOG performance status ≤ 2.
  • ≥ 18 years old.
  • Life expectancy > 6 months.
  • GTV diameter ≤ 5 cm.
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  • In case of de novo OMD and OMD recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed.
  • In case of OPD * and induced OMD*2 only 3 metastases (including the primary tumour) are allowed.
  • The metastatic lesion(s) must be visible on a CT- or MR- scan and suitable for treatment with SABR.
  • All metastatic sites are treated or planned for ablative therapy (including surgery) - for OPD only the sites in progression is required to fulfil this criterion. • A baseline scan within 28 days of inclusion (CT or PET- CT).
  • For spine/paraspinal targets, an MR scan is mandatory, if epidural growth cannot be precluded on the baseline CT scan.
  • No curative intended treatment option available.
  • An ablative strategy should be deemed clinically relevant and is at the discretion of the treating physician to decide.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patient cannot tolerate physical set up required for SABR.
  • Uncontrolled intercurrent illness.
  • Pregnancy.
  • Bilsky score ≥ 1b. If the patient is treated with surgery, a pre-operative Bilsky score ≥ 1b is an exclusion criterion as well. See appendix A for Bilsky score.
  • Presence of myelopathy from the target area.
  • Candidate for surgical treatment (determined by the institutions clinical oncologist, neurosurgeon or orthopaedic surgeon).
Show all 12Show fewer
  • For spine/paraspinal lesions where epidural growth cannot be precluded on the baseline CT scan: patients for whom an MR scan is contraindicated.
  • Mechanical instability and/or fracture risk *3.
  • For spine disease, involvement of ≥ three contiguous vertebrae.
  • Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
  • Patients with uncontrolled brain metastases.
  • If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix B. -

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg

  • Rigshospitalet

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Norway2 sites

  • Ålesund sjukehus

    Ålesund, 6026

  • St Olavs Universitetssykehus,

    Trondheim

Other trials in Norway

About this study

Official title: Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease - A Phase II Study

This is a prospective, investigator-initiated, phase II, multicentre-study, investigating the efficacy and toxicity of definitive SABR of osseous oligometastases, when pragmatically introduced into a daily clinical setting.

Read the detailed description

Patients with a histology or cytology proven non-hematological cancer and at least one lesion in the bones are eligible.

Patients with de novo- and induced oligometastatic disease, as well as patients with oligo-recurrence or oligo-progression disease can be included. A total of 67 patients will be enrolled.

The overall aim is to document long time follow-up in respect to local control rate, OS, PFS, rate of symptomatic skeletal event at the irradiated site(s), time to progression outside the radiation field at 1-, 2- and 5-years and acute/ late toxicities.

The primary endpoint is the rate of local control 1-year post SABR. Patients will have a CT scan and a clinical evaluation every 3 month after SABR according to the standard clinical follow-up program.

During the 1 year follow-up we also perform pain assessment (using the Numeric Pain Rating Scale), report the analgesic consumption and Quality of life (QoL) measured with EQ-5D-5L.

Two dose levels are offered with either 37.5 gy in 3 fractions or 30 gy in 3 fractions, prescribed to the GTV.

Being tested
SABR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SABRRadiation

    Two fractionation regimes are available (37.5 Gy in 3 fractions and 30.0 Gy in 3 fractions)

Study groups in NCT05101824
Study groupRoleWhat they receive
Single armOtherAll recruited patients are treated with SABR.
Receives: Radiation: SABR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. local control rate (LC) at 1-year post SABR

    Response evaluation is based on the interpretation of a experienced onco-radiologist and modifications from the MDACC response criteria's.

    Measured: 1-year post SABR

Secondary outcomes (14)

  1. Rate of Symptomatic Skeletal Event (SSE) at the irradiated site(s)

    Symptomatic Skeletal Event (SSE) of the irradiated site is defined as a radiographically verification of fracture (vertebral or non-vertebral, pathological or non-pathological), within or adjacent to the PTV of the irradiated site. The fracture must co-exist with one of the

    Measured: 3-, 6-, 12- and 24-months post SBRT

  2. Pain, change from baseline evaluated by "Numeric Pain Rating Scale (NPRS)"

    Response categories is based on patient reported pain scores (NPRS). The 11- 9 Protocol version 1.1, 01052020. Stereotactic ablative radiotherapy (SABR) of bony metastases in patients with oligometastatic disease - A phase II study point NPRS ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: Measured at 2-, 12-, 24-, 36- and 52-weeks post SBRT

  3. NCI CTCAE ≥ grade 3 toxicity

    Cummulated fraction of patients, who encounter one or more ≥ grade 3 NCI CTCAE toxicity within the first 3-months after SBRT.

    Measured: Measured at 2-, 12-weeks post SBRT

  4. NCI CTCAE ≥ grade 3 late toxicity

    Cummulated fraction of patients, who encounter one or more ≥ grade 3 NCI CTCAE toxicity from 3-months and onward after SBRT including patients who have unresolved early toxicity (encontered within the first 3-months), that is not resolved at the 24-weeks follow-up.

    Measured: Measured at 3-, 6-, 12- and 24-months post SBRT

  5. Local progression free survival

    Local progression free survival is defined as time from inclusion until progression of the irradiated lesion. Patients are not censored from analysis in case of new lesions outside the irradiated volume. The irradiated volume is defined as, within or adjacent to the PTV. Local progression free survival is reported as a continuos variable.

    Measured: continuous within 2-years post SBRT

  6. Progression-free survival (PFS)

    Progression-free survival is defined as time from inclusion until disease progression or death following symptoms/interventions: progression in pain (according to definition in section 3.5), development of neurological symptoms/ symptomatic spinal cord compression or a need for surgical intervention/ reirradiation. It should be concluded from the treating physician that the symptom/intervention is a result of the fracture. Vertebral fractures include end plate-only fractures. Analysis is done at a lesion level, lesion by lesion. Patients with a pathological fracture before the radiation therapy, will not be included for analysis

    Measured: Continuous and at 3-, 6-, 12- and 24-months post SBRT

  7. Time to progression (TTP) outside the radiation field

    Time to progression outside the radiation field is defined, as the time from inclusion until progression outside the radiation field, determined by a CT -, MR -, or PET-CT - scan. Outside the radiation field is defined as outside and not adjacent to the PTV.

    Measured: Continuous and at 3-, 6-, 12- and 24-months post SBRT

  8. Overall survival (OS)

    OS is defined as time from inclusion until death from any cause

    Measured: continuous till 2-year post SABR

  9. Quality of life (QoL) measured with EQ-5D-5L.

    Change from baseline in mobility using the 5-level system in EQ-5D-5L

    Measured: at 3-, 6-, 12- and 24-months post SBRT

  10. Quality of life (QoL) measured with EQ-5D-5L.

    Change from baseline in self-care score using the 5-level system in EQ-5D-5L

    Measured: at 3-, 6-, 12- and 24-months post SBRT

  11. Quality of life (QoL) measured with EQ-5D-5L.

    Change from baseline in usual activities score using the 5-level system in EQ-5D-5L.

    Measured: at 3-, 6-, 12- and 24-months post SBRT

  12. Quality of life (QoL) measured with EQ-5D-5L.

    Change from baseline in pain/discomfort score using the 5-level system in EQ-5D-5L.

    Measured: at 3-, 6-, 12- and 24-months post SBRT

  13. Quality of life (QoL) measured with EQ-5D-5L.

    Change from baseline in anxiety/depression score using the 5-level system in EQ-5D-5L.

    Measured: at 3-, 6-, 12- and 24-months post SBRT

  14. Quality of life (QoL) measured with EQ-5D-5L.

    Change from baseline in self assessed EQ visual analogue scale in EQ-5D-5L

    Measured: at 3-, 6-, 12- and 24-months post SBRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start1 Nov 2019
  3. Primary completion13 Jan 2023
  4. Study completion1 Nov 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Single arm, multicenter, phase 2 study
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101824
Sponsor's protocol ID
H-19039071
Status last verified
Jul 2023
First submitted
25 Mar 2021
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spindler NJ, Krog SM, Felter MVO, Hansen O, Nielsen TB, Suppli MH, Josipovic M, Poulsen LO, Rahma-Petersen F, Sand HMB, Abramova TM, Johansen M, Kornerup JS, Alsaker MD, Eefsen RL, Madsen K, Serup-Hansen E, Lindberg H, Vogelius IR, Behrens CP, Persson GF. Quality of life and pain-response after stereotactic ablative radiotherapy of oligometastatic bone metastases in the phase 2 BONY-M trial. Radiother Oncol. 2026 Sep 11;225:111774. doi: 10.1016/j.radonc.2026.111774. Online ahead of print.

    PubMed 42727887

  • Spindler NJ, Felter MVO, Hansen O, Nielsen TB, Suppli MH, Josipovic M, Poulsen LO, Rahma-Petersen F, Sand HMB, Abramova TM, Johansen M, Kornerup JS, Alsaker MD, Eefsen RL, Serup-Hansen E, Andersen MB, Geertsen P, Vogelius IR, Behrens CP, Persson GF. Stereotactic Ablative Radiation Therapy of Bone Metastases in an Oligometastatic Setting: One-Year Follow-Up of the BONY-M Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):320-329. doi: 10.1016/j.ijrobp.2025.07.1419. Epub 2025 Jul 24.

    PubMed 40714134

Questions about this trial

What is this clinical trial studying?

A study testing SABR in people with Oligometastatic Disease and Bone Metastases, run by Gitte Fredberg Persson MD PhD at 6 sites in 2 countries.

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 14 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark, Norway. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

local control rate (LC) at 1-year post SABR (time frame: 1-year post SABR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05101824, which also lists 2 linked publications.

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 11 Jul 2023.

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