Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
2 other identifiers
interventional
124
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedStudy Start
First participant enrolled
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedJanuary 23, 2026
January 1, 2026
3 years
June 10, 2022
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Severity as assessed by number of participants experiencing toxicity and adverse events
One month
Other Outcomes (2)
Pain as assessed by number of participants experiencing pain response
One month
Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale
One month
Study Arms (2)
Palliative radiation dose escalation
EXPERIMENTALThe 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.
Therapeutic benefit
NO INTERVENTIONRadiation 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
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, 08690, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701, United States
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, 10457, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08876, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew P Deek, MD
Rutgers Cancer Institute of New Jersey
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Radiation Oncology
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 15, 2022
Study Start
March 16, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share