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

Primary Purpose

Metastasis to Bone, Radiotherapy, Neoplasm Metastasis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Stereotactic body radiotherapy
3D-conformal radiotherapy
Sponsored by
Cancer Research Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastasis to Bone focused on measuring Stereotactic Body Radiotherapy, Spinal metastases, Bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radiotherapy department, GZA HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single fraction of 8 Gy

Single fraction of 20 Gy

Arm Description

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.

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.).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
Re-irradiation need
Need for re-irradiation of the treated lesion
Acute toxicity Measured with CTCAE version 5.0
Measured with CTCAE version 5.0
Late toxicity Measured with CTCAE version 5.0
Measured with CTCAE version 5.0
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).
Number of Subsequent Serious Skeletal events
Incidence of symptomatic pathologic fractures, radiation or surgery to bone, and spinal cord compression.

Full Information

First Posted
October 22, 2018
Last Updated
December 16, 2020
Sponsor
Cancer Research Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT03831243
Brief Title
A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
Acronym
ROBOMET
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Research Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis to Bone, Radiotherapy, Neoplasm Metastasis
Keywords
Stereotactic Body Radiotherapy, Spinal metastases, Bone metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single fraction of 8 Gy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Single fraction of 20 Gy
Arm Type
Experimental
Arm Description
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.).
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiotherapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
3D-conformal radiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Pain response
Description
Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.
Time Frame
4 weeks after RT visit
Secondary Outcome Measure Information:
Title
Incidence of pain flare
Description
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
Time Frame
24-48 hours after radiotherapy
Title
Duration of pain response
Description
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)
Time Frame
2 years after radiotherapy
Title
Re-irradiation need
Description
Need for re-irradiation of the treated lesion
Time Frame
2 years after radiotherapy
Title
Acute toxicity Measured with CTCAE version 5.0
Description
Measured with CTCAE version 5.0
Time Frame
3 months after radiotherapy
Title
Late toxicity Measured with CTCAE version 5.0
Description
Measured with CTCAE version 5.0
Time Frame
2 years after radiotherapy
Title
Impact of treatment on Quality of Life: EORTC quality of life questionnaire (QLQ) BM22
Description
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).
Time Frame
2 years after radiotherapy
Title
Number of Subsequent Serious Skeletal events
Description
Incidence of symptomatic pathologic fractures, radiation or surgery to bone, and spinal cord compression.
Time Frame
2 years after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piet Dirix, MD PhD
Phone
003234433737
Email
piet.dirix@gza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Mercier, MD
Phone
003234433737
Email
carole.mercier@gza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Verellen, PhD
Organizational Affiliation
Iridium Cancer Network
Official's Role
Study Director
Facility Information:
Facility Name
Radiotherapy department, GZA Hospitals
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piet Dirix, MD PhD
Phone
003234433737
Email
piet.dirix@gza.be
First Name & Middle Initial & Last Name & Degree
Carole Mercier, MD
Phone
0032344333737
Email
carole.mercier@gza.be
First Name & Middle Initial & Last Name & Degree
Piet Dirix, MD PhD
First Name & Middle Initial & Last Name & Degree
Carole Mercier, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31484505
Citation
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.
Results Reference
derived

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

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