Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
NCT ID: NCT05419518
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2023-03-16
2027-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
NCT00802659
Phase 1/2 Study to Determine Optimal Dose for Treating Bone Metastases Using Novel STAT-RT Workflow
NCT02145286
Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
NCT07090122
Stereotactic Radiosurgery Dose Escalation for Brain Metastases
NCT02390518
Rapid Radiation Therapy for Painful Osseous Metastatic Disease
NCT01391234
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
Dose escalation with 2D/ 3D-CRT in ten fractions in non-spine bone metastases will be evaluated. The total dose will range from 40-50 Gy depending on normal tissue constraints. This dose in ten fractions will lead to BED10 of 56 - 75 Gy which is higher than the BED10 39 Gy with 30 Gy in ten fractions.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Spinal metastasis
* Active compression of spinal cord/cauda equina
* Previous RT or SBRT to the same site
* \> 3 sites requiring radiation treatment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rutgers, The State University of New Jersey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matthew Pierre Deek
Assistant Professor, Radiation Oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew P Deek, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro2022000822
Identifier Type: OTHER
Identifier Source: secondary_id
152201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.