Clinical trial NCT03831243: A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
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
Overall status: COMPLETED
Phase: NA
Conditions: Metastasis to Bone
Radiotherapy
Neoplasm Metastasis
Keywords: Stereotactic Body Radiotherapy
Spinal metastases
Bone metastases
Lead sponsor: Cancer Research Antwerp
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain response
timeFrame: 4 weeks after RT visit
Secondary outcomes:
measure: Incidence of pain flare
timeFrame: 24-48 hours after radiotherapy
measure: Duration of pain response
timeFrame: 2 years after radiotherapy
measure: Re-irradiation need
timeFrame: 2 years after radiotherapy
measure: Acute toxicity Measured with CTCAE version 5.0
timeFrame: 3 months after radiotherapy
measure: Late toxicity Measured with CTCAE version 5.0
timeFrame: 2 years after radiotherapy
measure: Impact of treatment on Quality of Life: EORTC quality of life questionnaire (QLQ) BM22
timeFrame: 2 years after radiotherapy
measure: Number of Subsequent Serious Skeletal events
timeFrame: 2 years after radiotherapy
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Radiotherapy department, GZA Hospitals
state: Antwerp
Study officials:
affiliation: Iridium Cancer Network
name: Dirk Verellen, PhD
role: STUDY_DIRECTOR
References:
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.