NCT04063254

A Prospective Randomized Trial of High Dose Versus Standard Dose Stereotactic Radiotherapy for Pain Control in Patients With Bone Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

In the present study, we will prospectively evaluate the pain response and treatment failure rate to determine the most favorable radiation dose in single fraction stereotactic radiotherapy using the modern highly conformal technique for bone metastases. Our findings should be able to provide evidence-based recommendation to support the utilization of single fraction radiotherapy for value-based oncology practice.

Detailed 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 1. Worsening in the worst pain score by at least 3 by brief pain inventory survey 2. ≥ 50% increase in dose of opioid/narcotic medication 3. Development of pathologic fracture or cord/nerve compression indicative of surgical intervention 4. Unequivocal radiographic disease progression Secondary objectives 1. Compare pain response/control at the treated site(s) between the two treatment regimens by brief pain inventory survey 2. Assess health-related quality of life for palliative cancer care patients (EORTC QLQ-C15-PAL \& EORTC-BM22 Mandarin Taiwan) 3. Evaluate the analgescis use after irradiation 4. Evaluate acute and late adverse events associated with irradiation according to CTCAE criteria 5. To evaluate the local control of the treated index site(s) 6. To evaluate the patterns of failure 7. To evlaute overall survival 8. To evaluate the rate of re-irradiation, salvage surgery, interventional procedure, and MR-guided high intensity focused ultrasound at the treated site(s)

Conditions

• Bone Metastases
• Radiotherapy Side Effect

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiotherapy	High Dose (Arm A): Stereotactic radiotherapy with 12 or 16 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Standard-dose (Arm B): Stereotactic radiotherapy with 8 or 10 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).

Timeline

• Start date: 2019-08-30
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2019-08-21
• Last updated: 2019-08-21