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Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

Metastases, Neoplasm Clinical Trial

Official title:
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases

Clinical Trial Summary

The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases

Clinical Trial Description

The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy. Primary Objective: To evaluate improvement of complete pain response rate in painful non-spine bone metastases and painful non-bone metastases with dose escalated radiation using a ten fraction radiation regimen Secondary Objectives: To evaluate best pain response To evaluate mean pain scores To evaluate the duration of pain response To evaluate the changes in quality-of-life following radiation To evaluate the rates of retreatment with radiation secondary to disease or symptom progression To evaluate treatment related toxicity ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05419518
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact Matthew P Deek, MD
Phone 732-253-3941
Email Deekmp@cinj.Rutgers.edu
Status Recruiting
Phase Phase 2
Start date March 16, 2023
Completion date April 1, 2024
View Details
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