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

Bone Metastases Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04063254
Study type Interventional
Source National Taiwan University Hospital
Contact Yun Chiang
Phone 0223123456
Email chiangyun@ntuh.gov.tw
Status Not yet recruiting
Phase Phase 2
Start date August 30, 2019
Completion date August 30, 2021
View Details
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