← Back to Search

Radiation

Biology-Guided Radiation Therapy for Bone Cancer

Phase 1
Recruiting
Led By Yi-Jen Chen
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
Must not have
Untreated spinal cord compression
Pathologic fracture at the evaluated site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new type of radiation therapy called biology-guided radiation therapy (BgRT) as a one-time treatment for patients with painful bone cancer that has spread. The traditional treatment for this type

Who is the study for?
This trial is for patients with painful cancer that has spread to the bone. Participants must have a life expectancy of at least 3 months, be able to lie still for treatment, and provide written informed consent. Those who are pregnant, breastfeeding, or have certain metal implants near the treatment area cannot join.
What is being tested?
The study tests a single-dose biology-guided radiation therapy (BgRT) using live data from PET scans to target active tumors in bones. It aims to see if BgRT can effectively relieve pain without needing retreatment like standard therapies.
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, nausea, and temporary pain flare-ups post-treatment. Long-term risks could involve damage to surrounding tissues or organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and perform daily activities.
Select...
My brain metastases have been treated and stable for 3 months.
Select...
I have painful bone metastases with a pain score of at least 2.
Select...
I haven't taken any systemic therapy for at least a week and won't for a week after the study treatment.
Select...
I am 18 years old or older.
Select...
My bone lesion is between 1.5 and 5 cm in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have untreated spinal cord compression.
Select...
I have a broken bone at the site being examined.
Select...
I have serious health issues that prevent me from receiving radiotherapy.
Select...
I have had radiation therapy on the area being considered for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Pain response
Secondary study objectives
Incidence of clinician-related chronic toxic effects
Patient-reported health related quality of life (QOL)
Radiographic evidence of disease progression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (BgRT)Experimental Treatment4 Interventions
Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200
Image Guided Radiation Therapy
2016
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,556 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,441 Total Patients Enrolled
Yi-Jen ChenPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
320 Total Patients Enrolled
~16 spots leftby Jan 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top