Status:
UNKNOWN
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Neoplasm Metastases
Metastases, Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Add...
Detailed 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 ther...
Eligibility Criteria
Inclusion
- 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 during the treatment period and for at least 120 days after the last dose of study treatment.
- A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment.
Exclusion
- Metastasis from a highly radiosensitive tumor (eg, lymphoma, myeloma, germ cell tumor)
- Spinal metastasis
- Active compression of spinal cord/cauda equina
- Previous RT or SBRT to the same site
- \> 3 sites requiring radiation treatment
Key Trial Info
Start Date :
March 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT05419518
Start Date
March 16 2023
End Date
April 1 2024
Last Update
November 14 2023
Active Locations (7)
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1
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States, 08690
2
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
3
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, United States, 10457
4
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901