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

Cancer Research Antwerp126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Metastasis to Bone Radiotherapy Neoplasm Metastasis

Interventions

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 radiotherapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain response

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 Outcomes

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

Time frame: 24-48 hours after radiotherapy

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)