Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05419518

Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

Led by Rutgers, The State University of New Jersey · Updated on 2026-01-23

124

Participants Needed

7

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

RWJBarnabas Health - Robert Wood Johnson University Hospital

Hamilton, New Jersey, United States, 08690

Not Yet Recruiting

2

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, United States, 08701

Actively Recruiting

3

RWJBarnabas Health - Saint Barnabas Medical Center

Livingston, New Jersey, United States, 10457

Actively Recruiting

4

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

5

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

6

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, United States, 08876

Actively Recruiting

7

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, United States, 08755

Actively Recruiting

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Research Team

M

Matthew P Deek, MD

CONTACT

S

Salma Jabbour, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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