Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
Rutgers, The State University of New Jersey
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
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 ra…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have provided signed informed consent for the trial * Aged ≥18 years at the time of informed consent * Histologic proof of malignancy * Radiologic or histologic evidence of bone metastases or non-bone metastases * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥3 * Pain Score ≥ 3 * Life expectancy of six months or more * Willing and able to comply with all aspects of the protocol * A female participant is eligible to participate if she is not pregnant and not breastfeeding * Woman of childbearing potential who agrees to follow contraceptive guidance duri…