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

NCT03831243 | Completed

• 1 other identifier: CTOR18072GZA
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Metastasis to Bone; Radiotherapy; Neoplasm Metastasis

Keywords

Stereotactic Body Radiotherapy; Spinal metastases; Bone metastases

Outcome Measures

Primary Outcomes (1)

• Pain response

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

  4 weeks after RT visit

Secondary Outcomes (7)

• Incidence of pain flare

  24-48 hours after radiotherapy

• Duration of pain response

  2 years after radiotherapy

• Re-irradiation need

  2 years after radiotherapy

• Acute toxicity Measured with CTCAE version 5.0

  3 months after radiotherapy

• Late toxicity Measured with CTCAE version 5.0

  2 years after radiotherapy

Study Arms (2)

Single fraction of 8 Gy

ACTIVE COMPARATOR

The 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.

Radiation: 3D-conformal radiotherapy

Single fraction of 20 Gy

EXPERIMENTAL

Within 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.).

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapy RADIATION

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.

Single fraction of 20 Gy

3D-conformal radiotherapy RADIATION

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.

Single fraction of 8 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Research Antwerp: lead

Study Sites (1)

Radiotherapy department, GZA Hospitals

Wilrijk, Antwerp, 2610, Belgium

Location

Related Publications (2)

• 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.

  PMID: 40340551 DERIVED

• 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.

  PMID: 31484505 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dirk Verellen, PhD

  Iridium Cancer Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: February 5, 2019
• Study Start: April 9, 2019
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: February 7, 2024

Record last verified: 2022-03

Locations

BE (1)