NCT05419518 · Rutgers, The State University of New Jersey
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
What this study is about
The investigators hypothesize that with gradually increasing doses 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Safety as assessed by number of participants experiencing adverse events
Time frame: One month
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 c
Where
- Hamilton, New Jersey
- Lakewood, New Jersey
- Livingston, New Jersey
- New Brunswick, New Jersey
- Somerset, New Jersey
- Toms River, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations