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

Neoplasm Metastasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831243
• Other study ID #: CTOR18072GZA
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: October 26, 2023

Study information

• Verified date: March 2022
• Source: Cancer Research Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastasis to Bone
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Radiotherapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Radiotherapy department, GZA Hospitals	Wilrijk	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain response	Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.	4 weeks after RT visit
Secondary	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	24-48 hours after radiotherapy
Secondary	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)	2 years after radiotherapy
Secondary	Re-irradiation need	Need for re-irradiation of the treated lesion	2 years after radiotherapy
Secondary	Acute toxicity Measured with CTCAE version 5.0	Measured with CTCAE version 5.0	3 months after radiotherapy
Secondary	Late toxicity Measured with CTCAE version 5.0	Measured with CTCAE version 5.0	2 years after radiotherapy
Secondary	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).	2 years after radiotherapy
Secondary	Number of Subsequent Serious Skeletal events	Incidence of symptomatic pathologic fractures, radiation or surgery to bone, and spinal cord compression.	2 years after radiotherapy