Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOman Ministry of Health
About this trial
This prospective randomised pilot feasibility study will compare single-fraction radiotherapy (8 Gy × 1) with multifraction radiotherapy (20 Gy in 5 fractions) for the palliation of painful bone metastases. The study will evaluate pain response at 4 weeks following radiotherapy, together with feasibility, treatment compliance, toxicity, pain flare, retreatment, patient convenience and resource utilisation. The study will generate preliminary data to inform the design of a future definitive randomised trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Histologically proven malignancy
Radiological evidence of bone or spine metastases
Pain score ≥4 on Numeric Rating Scale (NRS-11)
Disqualifiers
Spinal cord compression requiring emergency therapy
Previous radiotherapy to same site
Unstable pathological fracture requiring surgery
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Single-Fraction Radiotherapy (8Gy x 1#)
RadiationVMAT-based external beam radiotherapy planned to deliver 8 Gy in a single fraction with CBCT-based image guidance for the palliation of painful bone metastasis
Multifraction Radiotherapy (20 Gy in 5 #)
RadiationVMAT-based external beam radiotherapy planned to deliver 20 Gy in Five fractions of 4 Gy each with daily CBCT-based image guidance for the palliation of painful bone metastasis
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Single-Fraction Radiotherapy (SFRT)Experimental treatment 1 intervention
Group B: Multifraction Radiotherapy (MFRT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of target sample recruited
The percentage of the planned target sample successfully recruited during the recruitment period. Recruitment feasibility will be interpreted using predefined traffic-light criteria: Green ≥80% (feasibility achieved), Amber 70-79% (borderline feasibility requiring review), and Red \<70% (feasibility not achieved and requiring review).
Time frame
From study initiation through completion of the recruitment period.2
Percentage of participants completing assigned radiotherapy
The percentage of randomised participants who complete the assigned radiotherapy treatment according to the study protocol. Treatment completion feasibility will be interpreted using predefined traffic-light criteria: Green ≥90% (feasibility achieved), Amber 80-89% (borderline feasibility requiring review), and Red \<80% (feasibility not achieved and requiring review).
Time frame
From randomisation through completion of assigned radiotherapy.3
Percentage of participants completing 3-month follow-up
The percentage of randomised participants who complete the required study follow-up through 3 months after radiotherapy. Follow-up feasibility will be interpreted using predefined traffic-light criteria: Green ≥80% (feasibility achieved), Amber 70-79% (borderline feasibility requiring review), and Red \<70% (feasibility not achieved and requiring review).
Time frame
From randomisation through 3 months after radiotherapy.4
Percentage of participants with complete required study data
The percentage of participants with complete required study data according to the study data collection requirements. Data completeness will be interpreted using predefined traffic-light criteria: Green ≥90% (feasibility achieved), Amber 80-89% (borderline feasibility requiring review), and Red \<80% (feasibility not achieved and requiring review).
Time frame
From study initiation through 3 months after radiotherapy.Secondary outcomes
1
Percentage of participants achieving overall pain response at 4 weeks.
Overall pain response will be assessed using the NRS-11 and analgesic use. Pain response is defined as a reduction of at least 2 points in pain from baseline with no escalation in analgesic use. The percentage of participants achieving pain response will be compared between the SFRT and MFRT groups.
Time frame
4 weeks after radiotherapy2
Percentage of participants requiring retreatment
The percentage of participants requiring repeat radiotherapy to the treated sitefor persisten or recurrence of pain will be recorded and compared between the SFRT and MFRT groups.
Time frame
From completion of radiotherapy through 3 months after radiotherapy3
Percentage of participants experiencing pain flare
Pain flare following radiotherapy will be recorded and compared between the SFRT and MFRT groups. Pain flare is defined as increase in NRS pain score by ≥2 points without reduction in analgesic use, or Increase in analgesic requirement by ≥25% without improvement in pain score, followed by return to the baseline pain level or analgesic requirement within 10 days after radiotherapy.
Time frame
From completion of radiotherapy through 10 days after radiotherapy.4
Percentage of participants achieving overall pain response at 2 weeks and 3 months
Overall pain response will be assessed using the NRS-11 and analgesic use. Pain response is defined as a reduction of at least 2 points in pain from baseline with no escalation in analgesic use. The percentage of participants achieving pain response will be recorded at 2 weeks and 3 months after radiotherapy and compared between the SFRT and MFRT groups.
Time frame
2 weeks and 3 months after radiotherapyOther outcomes
1
Number of participants receiving radiotherapy to new painful metastatic sites
The number of participants who receive radiotherapy to new painful metastatic sites during the 3-month follow-up period will be recorded descriptively. This outcome reflects the occurrence of new painful metastatic disease during follow-up and is not intended to assess the efficacy of SFRT versus MFRT.
Time frame
From completion of radiotherapy through 3 months after radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Oman Ministry of Health
Lead sponsor
Royal Hospital, Oman
Collaborator
Source ClinicalTrials.gov
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