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
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
A minimum of three daily radiation therapy treatments are required in any given week. Any missed radiation treatments will be made up at the end of the treatment schedule, such that the total number of delivered 5 Gy fractions remains ten.
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States
NOT_YET_RECRUITINGRWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
RECRUITINGRWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, United States
RECRUITINGRobert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RECRUITINGCancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGRWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States
RECRUITINGRWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States
RECRUITINGSafety as assessed by number of participants experiencing adverse events
Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)
Time frame: One month
Severity as assessed by number of participants experiencing toxicity and adverse events
This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting
Time frame: One month
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