Recruiting
Phase 2

Palliative Radiation

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05419518

Conditions

Neoplasm Metastases

Metastases, Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EXTERNAL BEAM RADIATION

Study Details

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. 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

Neoplasm Metastases

Metastases, Neoplasm

Study ID

NCT05419518

Start date

Mar 16, 2023

Status verified date

May, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Palliative radiation dose escalation

The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.

no intervention: Therapeutic benefit

Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.

Interventions

EXTERNAL BEAM RADIATION

A minimum of three daily radiation therapy treatments are required in any given week. Any missed radiation treatments will be made up at the end of the treatment schedule, such that the total number of delivered 5 Gy fractions remains ten.

Primary outcome measure

  • Safety as assessed by number of participants experiencing adverse events [ Time Frame: One month ]

Central Contacts and Locations

Central contacts

Matthew P Deek, MD

732-253-3941Deekmp@cinj.Rutgers.edu

Salma Jabbour, MD

732-253-3961jabbousk@cinj.rutgers.edu

Locations

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Recruiting

Lakewood, New Jersey, United States, 08701

RWJBarnabas Health - Saint Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 10457

Contacts

Matthew P Deek, MD

732-253-3941Deekmp@cinj.Rutgers.edu

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

RWJBarnabas Health - Robert Wood Johnson University Hospital

Recruiting

Somerset, New Jersey, United States, 08876

Contacts

Matthew P Deek, MD

732-253-3941Deekmp@cinj.Rutgers.edu

RWJBarnabas Health - Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Metastase
  • Bone Neoplasms
  • Dose Fractionation, Radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-06-02.