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Radiation Therapy
FLASH Radiotherapy for Bone Metastases (FAST-02 Trial)
N/A
Recruiting
Led By John Breneman, MD
Research Sponsored by Varian, a Siemens Healthineers Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from start of treatment until 6 months post treatment.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new, very high-dose radiation treatment for people with bone cancer that has spread to their chest. They want to see if it causes side effects and if it relieves pain.
Who is the study for?
Adults over 18 with 1-3 painful bone metastases in the thorax, expected to live more than 6 months, and can follow the study plan. Excluded are those with metal implants in the treatment area, prior radiation or therapy that affects tissue response to radiation within specific timeframes before/after treatment, pregnant or nursing women, and certain medical conditions.
What is being tested?
The trial is testing FLASH Radiotherapy for pain relief and safety in patients with painful bone metastases in the chest area. This new type of radiotherapy is given at much faster rates than conventional treatments.
What are the potential side effects?
Potential side effects may include typical reactions associated with radiotherapy such as skin irritation at the treatment site, fatigue, nausea, and inflammation of surrounding tissues. Specific side effects related to FLASH Radiotherapy's high-speed delivery will be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from start of treatment until 6 months post treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from start of treatment until 6 months post treatment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of pain relief using patient reported pain questionnaire for overall pain score
Pain
Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy.
+1 moreSecondary study objectives
Workflow feasibility - delays in study treatment
Workflow feasibility - time on table
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: FLASH radiotherapy for painful bone metastasis(-es)Experimental Treatment1 Intervention
FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FLASH Radiotherapy
2020
N/A
~10
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Who is running the clinical trial?
Varian, a Siemens Healthineers CompanyLead Sponsor
34 Previous Clinical Trials
7,217 Total Patients Enrolled
John Breneman, MDPrincipal InvestigatorMedical Director Cincinnati Children's/UC Health Proton Therapy Center
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any local treatments in the last 2 weeks that could affect pain assessment.I cannot receive chest radiation due to health reasons.I am 18 years old or older.My bone cancer can be targeted with a specific size of radiation treatment.I have a condition or genetic risk that makes me more sensitive to radiation.My treatment plan is approved by healthcare professionals.I will not have certain cancer treatments 2 weeks before or 1 week after my radiation.I have more than 3 painful bone metastases in my chest area needing radiation therapy.My radiation treatment areas have not overlapped.I have 1 to 3 painful bone metastases in my upper body needing treatment.I have or had lung inflammation due to radiation or other causes.I have had a bone fracture in the area being treated.I have metal implants in the area that needs treatment.I don't have lasting side effects from previous treatments, except for hair loss or nerve issues.
Research Study Groups:
This trial has the following groups:- Group 1: FLASH radiotherapy for painful bone metastasis(-es)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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