Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
Recruiting now · Phase 2
Conditions studied: Neoplasm Metastases, Metastases, Neoplasm
In brief
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
Key facts
- Study ID
- NCT05419518
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 124
- Starts
- 2023-03-16
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (enrolling)
- RWJBarnabas Health - Saint Barnabas Medical Center — Livingston, New Jersey, United States (enrolling)
- RWJBarnabas Health - Community Medical Center — Toms River, New Jersey, United States (enrolling)
- Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
- RWJBarnabas Health - Robert Wood Johnson University Hospital — Somerset, New Jersey, United States (enrolling)
- RWJBarnabas Health - Robert Wood Johnson University Hospital — Hamilton, New Jersey, United States
Full record on ClinicalTrials.gov
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