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

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ClinicalTrials.gov Identifier: NCT03831243
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Cancer Research Antwerp

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.

Condition or disease Intervention/treatment Phase
Metastasis to Bone Radiotherapy Neoplasm Metastasis Radiation: Stereotactic body radiotherapy Radiation: 3D-conformal radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023

Arm Intervention/treatment
Active Comparator: Single fraction of 8 Gy
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
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.

Experimental: Single fraction of 20 Gy
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
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831243


Contacts
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Contact: Piet Dirix, MD PhD 003234433737 piet.dirix@gza.be
Contact: Carole Mercier, MD 003234433737 carole.mercier@gza.be

Locations
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Belgium
Radiotherapy department, GZA Hospitals Recruiting
Wilrijk, Antwerp, Belgium, 2610
Contact: Piet Dirix, MD PhD    003234433737    piet.dirix@gza.be   
Contact: Carole Mercier, MD    0032344333737    carole.mercier@gza.be   
Principal Investigator: Piet Dirix, MD PhD         
Sub-Investigator: Carole Mercier, MD         
Sponsors and Collaborators
Cancer Research Antwerp
Investigators
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Study Director: Dirk Verellen, PhD Iridium Cancer Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cancer Research Antwerp
ClinicalTrials.gov Identifier: NCT03831243     History of Changes
Other Study ID Numbers: CTOR18072GZA
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Research Antwerp:
Stereotactic Body Radiotherapy
Spinal metastases
Bone metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes