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

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

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

Study Overview

• Status: Recruiting
• Conditions: Metastases, Neoplasm; Neoplasm Metastases
• Intervention / Treatment: Biological: EXTERNAL BEAM RADIATION

Detailed Description

The purpose of this study is to prospectively evaluate dose escalation and pain response in patients with painful non-spinal bone metastases and painful non-bone metastases treated with radiation therapy.

Primary Objective:

To evaluate improvement of complete pain response rate in painful non-spine bone metastases and painful non-bone metastases with dose escalated radiation using a ten fraction radiation regimen

Secondary Objectives:

To evaluate best pain response To evaluate mean pain scores To evaluate the duration of pain response To evaluate the changes in quality-of-life following radiation To evaluate the rates of retreatment with radiation secondary to disease or symptom progression To evaluate treatment related toxicity

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Salma Jabbour, MD; Phone Number: 732-253-3961; Email: jabbousk@cinj.rutgers.edu
• Study Contact Backup: Name: Matthew P Deek, MD; Phone Number: 732-253-3941; Email: Deekmp@cinj.Rutgers.edu

Study Locations

• United States
  • New Jersey
    • Hamilton, New Jersey, United States, 08690
      • Not yet recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital
      • Contact: Matthew P Deek, MD; Phone Number: 732-253-3941; Email: Deekmp@cinj.Rutgers.edu
    • Lakewood, New Jersey, United States, 08701
      • Recruiting
      • RWJBarnabas Health - Monmouth Medical Center Southern Campus
    • Livingston, New Jersey, United States, 10457
      • Recruiting
      • RWJBarnabas Health - Saint Barnabas Medical Center
      • Contact: Matthew P Deek, MD; Phone Number: 732-253-3941; Email: Deekmp@cinj.Rutgers.edu
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Robert Wood Johnson University Hospital
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Cancer Institute Of New Jersey
    • Somerset, New Jersey, United States, 08876
      • Recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital
      • Contact: Matthew P Deek, MD; Phone Number: 732-253-3941; Email: Deekmp@cinj.Rutgers.edu
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • RWJBarnabas Health - Community Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by number of participants experiencing adverse events	Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity as assessed by number of participants experiencing toxicity and adverse events	This study will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity and Adverse Event reporting	One month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as assessed by number of participants experiencing pain response	will be measured according to the international consensus guidelines on palliative RT13. Pain assessment will be based on scores in Numerical Rating Pain Scale (NRPS), Visual analog scale (VAS) and Opioid analgesic use (an oral morphine equivalent dose (OMED)) in mg. Complete response is defined as a pain score of 0 on a scale from 0 to 10 and without an increase in OMED medication use. Partial response is defined as a decline of ≥2 points in pain score without analgesic increase or a decline in use of OMED of at least 25% or more from baseline without an increase in pain. Pain progression (PP) is an increase of ≥2 points without a change in OMED use or an increase of 25% or more in OMED compared with baseline with the pain score stable or one point above baseline.	One month
Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale	Quality-of-life (QOL) instruments specific to participants with bone metastases or to those receiving palliative care have been developed in recent years. The Brief Pain Inventory (BPI) have shown excellent reliability and validity in assessing participants with bone metastases fourteen. BPI will be used for QOL assessment at baseline and one month after treatment.The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.	One month

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Matthew P Deek, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Metastase; Bone Neoplasms; Dose Fractionation, Radiation
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Bone Neoplasms
• Other Study ID Numbers: 152201; Pro2022000822 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No