Palliative radiation treatment for painful bone and non-bone metastases
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metastases
PHASE2 · Rutgers, The State University of New Jersey · NCT05419518
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Drugs / interventions | radiation |
| Locations | 7 sites (Hamilton, New Jersey and 6 other locations) |
| Trial ID | NCT05419518 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed malignancies and painful non-spinal bone or non-bone metastases.
Not a fit: Patients with highly radiosensitive tumors or spinal metastases may not benefit from this treatment.
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 performed: Other studies have shown promising results with similar dose escalation approaches in radiation therapy for metastatic pain management.
Eligibility criteria
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 this trial is running
Hamilton, New Jersey and 6 other locations
- RWJBarnabas Health - Robert Wood Johnson University Hospital — Hamilton, New Jersey, United States (NOT_YET_RECRUITING)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neoplasm Metastases, Metastases, Neoplasm, Metastase, Bone Neoplasms, Dose Fractionation, Radiation