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Metastasis to BoneROBOMETNCT03831243

A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases

A study testing Stereotactic body radiotherapy and 3D-conformal radiotherapy in people with Metastasis to Bone and Radiotherapy, run by Cancer Research Antwerp at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic body radiotherapy and 3D-conformal radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteBelgium
Study dates
9 Apr 2019to 26 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • Histologically confirmed malignancy.
  • Pain score ≥ 2 on a scale from 0 to 10.
  • Radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain.
  • Lesions ≤ 5cm in largest diameter.
  • Per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below.
  • No more than 3 painful lesions needing treatment.
Show all 10Show fewer
  • Life expectancy estimated at > 3 months.
  • Patients who have received the information sheet and signed the informed consent form.
  • Patients must be willing to comply with scheduled visits, treatment plan, and other study procedures.
  • Patients with a public and/or private health insurance coverage.

Who cannot join

  • Myeloma.
  • Bone metastasis in previously irradiated sites.
  • Previous radioisotope treatment for bone metastases.
  • Complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression [16].
  • Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study.
  • Individual deprived of liberty or placed under guardianship.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Radiotherapy department, GZA Hospitals

    Wilrijk, Antwerp, 2610

Other trials in Belgium

About this study

Official title: A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases

This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). The primary aim of this trial is to double the complete response rate. Secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, HRQoL through patient-reported outcome measures (PROMs), pain flare, and re-irradiation need.

Being tested
Stereotactic body radiotherapy, 3D-conformal radiotherapy
Keywords
Stereotactic Body Radiotherapy, Spinal metastases, Bone metastases
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • Stereotactic body radiotherapyRadiation

    Treatment will be prescribed to the periphery of the target, i.e. 80% of the dose should cover 95% of the PTV. The organ at risk (OAR) dose constraints will be in accordance with the recommendations from the report of the American Association of Physicists in Medicine (AAPM) task group 101. Image-guidance will consist of cone-beam CT in combination with 6 degrees of freedom corrections using robotic couch.

  • 3D-conformal radiotherapyRadiation

    In the standard setting, 95% of the PTV should receive 95% of the prescribed dose while near maximum dose (Dnear-max) in the PTV should not exceed 107%. Image-guidance will consist of portal images showing the relevant bony anatomy.

Study groups in NCT03831243
Study groupRoleWhat they receive
Single fraction of 8 GyActive comparatorThe current standard treatment will be prescribed, i.e. a 3D-conformal radiotherapy of a single fraction dose of 8.0 Gy to the metastasis with a planning target volume (PTV) margin for set-up and positioning uncertainties of 1 cm. This can be performed at any linear accelerator.
Receives: Radiation: 3D-conformal radiotherapy
Single fraction of 20 GyExperimentalWithin the framework of stereotactic body radiotherapy, a single fraction dose of 20.0 Gy will be delivered to the metastasis using a PTV margin of 3-5 mm based on high-precision image-guided radiotherapy (IGRT). Therefore, only linear accelerators with the European Organization for Radiotherapy \& Oncology advisory committee on radiation oncology practice (ESTRO-ACROP) specifications for SBRT can be accepted. A risk-adapted approach will be applied, aiming for the highest possible dose no less than 16 Gy, while respecting the tolerances of critical organs at risk (e.g. spinal cord, cauda equina, brainstem etc.).
Receives: Radiation: Stereotactic body radiotherapy

What is being measured

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

  1. Pain response

    Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.

    Measured: 4 weeks after RT visit

Secondary outcomes (7)

  1. Incidence of pain flare

    Number of participants with increase in pain score of 2 or more above baseline at the treated site with stable OMED, or an increase of 25% or more in OMED compared with baseline with the pain score stable or 1 point above baseline

    Measured: 24-48 hours after radiotherapy

  2. Duration of pain response

    Time until pain progression (defined as an increase in pain score of 2 or more above baseline at the treated site with stable daily oral morphine equivalent, or an increase of 25% or more in daily oral morphine equivalent (OMED) compared with baseline with the pain score stable or 1 point above baseline)

    Measured: 2 years after radiotherapy

  3. Re-irradiation need

    Need for re-irradiation of the treated lesion

    Measured: 2 years after radiotherapy

  4. Acute toxicity Measured with CTCAE version 5.0

    Measured with CTCAE version 5.0

    Measured: 3 months after radiotherapy

  5. Late toxicity Measured with CTCAE version 5.0

    Measured with CTCAE version 5.0

    Measured: 2 years after radiotherapy

  6. Impact of treatment on Quality of Life: EORTC quality of life questionnaire (QLQ) BM22

    Using the EORTC quality of life questionnaire for Bone Metastases (QLQ BM22) to measure impact of bone metastases on QoL [min score 0 - max score 100]. A high score represents a high level of symptomatology. The score is calculated by applying a linear transformation on the scores to each answer of the 22 question-long questionnaire (cfr. EORTC mannual).

    Measured: 2 years after radiotherapy

  7. Number of Subsequent Serious Skeletal events

    Incidence of symptomatic pathologic fractures, radiation or surgery to bone, and spinal cord compression.

    Measured: 2 years after radiotherapy

Timeline

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

  1. First posted5 Feb 2019
  2. Study start9 Apr 2019
  3. Primary completion26 Oct 2023
  4. Study completion26 Oct 2023

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
Randomised
Intervention model
Parallel groups
Model description
All subjects will be randomly assigned in a 1:1 ratio to receive either a single fraction of 8.0 Gy to the painful bone metastasis through 3D-CRT (control arm) or a single fraction of 20.0 Gy to the painful bone metastasis through SBRT (experimental arm).
Masking
Single blind
Who is masked
Participant
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03831243
Sponsor's protocol ID
CTOR18072GZA
Acronym
ROBOMET
Status last verified
Mar 2022
First submitted
22 Oct 2018
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mercier C, Billiet C, Ost P, Vandecasteele K, De Kerf G, Claessens M, Van Laere S, Vermeulen P, Dirix L, Lievens Y, Verellen D, Dirix P. Dose-Escalated Stereotactic Versus Conventional Radiotherapy for Painful Bone Metastases (ROBOMET): A Multicenter, Patient-Blinded Randomized Clinical Trial. J Clin Oncol. 2025 Jul;43(19):2164-2172. doi: 10.1200/JCO-24-01447. Epub 2025 May 8.

    PubMed 40340551

  • Mercier C, Dirix P, Ost P, Billiet C, Joye I, Vermeulen P, Lievens Y, Verellen D. A phase III randomized-controlled, single-blind trial to improve quality of life with stereotactic body radiotherapy for patients with painful bone metastases (ROBOMET). BMC Cancer. 2019 Sep 4;19(1):876. doi: 10.1186/s12885-019-6097-z.

    PubMed 31484505

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic body radiotherapy and 3D-conformal radiotherapy in people with Metastasis to Bone and Radiotherapy, run by Cancer Research Antwerp at 1 site 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pain response (time frame: 4 weeks after RT visit). 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 NCT03831243, 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 7 Feb 2024.

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