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NCT Number: NCT03831243

A 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.

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Key information

Conditions

Metastasis to Bone Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiotherapy department, GZA Hospitals

Wilrijk, Antwerp, 2610, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain response

    Time frame: 4 weeks after RT visit

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

Secondary outcomes

  1. Incidence of pain flare

    Time frame: 24-48 hours after radiotherapy

    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

  2. Duration of pain response

    Time frame: 2 years after radiotherapy

    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)

  3. Re-irradiation need

    Time frame: 2 years after radiotherapy

    Need for re-irradiation of the treated lesion

  4. Acute toxicity Measured with CTCAE version 5.0

    Time frame: 3 months after radiotherapy

    Measured with CTCAE version 5.0

  5. Late toxicity Measured with CTCAE version 5.0

    Time frame: 2 years after radiotherapy

    Measured with CTCAE version 5.0

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

    Time frame: 2 years after radiotherapy

    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).

  7. Number of Subsequent Serious Skeletal events

    Time frame: 2 years after radiotherapy

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

Sponsors and collaborators

Lead sponsor

Cancer Research Antwerp

Other

Registry information

Official study title

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

Acronym: ROBOMET

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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