Palliative radiation treatment for painful bone and non-bone metastases
Official title: Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
Run by Rutgers, The State University of New Jersey · NCT05419518 · Data updated 2026-11-12
This study is testing if higher doses of radiation can help reduce pain and improve quality of life for people with painful bone and non-bone cancer spread.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 124 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Hamilton, New Jersey and 6 other locations) |
| Status | Recruiting |
| Started | March 16, 2023 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT05419518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with histologically confirmed malignancies and painful non-spinal bone or non-bone metastases.
✕Probably not a fit
Patients with highly radiosensitive tumors or spinal metastases may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of dose escalated radiation therapy for patients suffering from painful non-spinal bone metastases and painful non-bone metastases. The investigators will administer radiation doses of 40-50 Gy in ten fractions to assess improvements in pain response rates and overall quality of life. The study will also monitor treatment-related toxicity and the need for retreatment due to disease progression. By comparing pain scores and response rates, the study seeks to determine the optimal radiation regimen for these patients.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve quality of life for patients with painful metastases.
How similar studies have gone: Other studies have shown promising results with similar dose escalation approaches in radiation therapy for metastatic pain management.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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 Criteria: * 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
Where it's running
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RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States Recruiting -
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, United States Recruiting -
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States Recruiting -
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States Recruiting -
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States Recruiting -
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States Recruiting
Show 1 more location
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RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States Not yet recruiting
Study contacts
- Principal investigator: Matthew P Deek, MD — Rutgers Cancer Institute of New Jersey
- Study coordinator: Matthew P Deek, MD
- Email: Deekmp@cinj.Rutgers.edu
- Phone: 732-253-3941
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.