A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bone Metastases
- Radiotherapy Side Effect
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
Primary objective To evaluate dose regimen for pain control in terms of rate of treatment failure, defined as the first occurrence of any of the following events, at 3 months Worsening in the worst pain score by at least 3 by brief pain inventory survey ? 50% increase in dose of opioid/narcotic medi...
Primary objective To evaluate dose regimen for pain control in terms of rate of treatment failure, defined as the first occurrence of any of the following events, at 3 months Worsening in the worst pain score by at least 3 by brief pain inventory survey ? 50% increase in dose of opioid/narcotic medication Development of pathologic fracture or cord/nerve compression indicative of surgical intervention Unequivocal radiographic disease progression Secondary objectives Compare pain response/control at the treated site(s) between the two treatment regimens by brief pain inventory survey Assess health-related quality of life for palliative cancer care patients (EORTC QLQ-C15-PAL & EORTC-BM22 Mandarin Taiwan) Evaluate the analgescis use after irradiation Evaluate acute and late adverse events associated with irradiation according to CTCAE criteria To evaluate the local control of the treated index site(s) To evaluate the patterns of failure To evlaute overall survival To evaluate the rate of re-irradiation, salvage surgery, interventional procedure, and MR-guided high intensity focused ultrasound at the treated site(s)
Tracking Information
- NCT #
- NCT04063254
- Collaborators
- Not Provided
- Investigators
- Not Provided