Trial Summary
What is the purpose of this trial?This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis). Palliative radiation therapy using external beam radiation therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by cancer.
Eligibility Criteria
This trial is for cancer patients with pain from tumors that have spread to their bones, excluding the skull, hands, and feet. They must be experiencing significant pain or taking strong pain medication daily. Prior radiation or surgery at the painful site disqualifies them. Patients should be able to consent, not pregnant, and expected to live at least 12 more weeks.Inclusion Criteria
Ability to understand and sign an Institutional Review Board (IRB)-approved informed consent document
Life expectancy of at least 12 weeks as deemed by treating oncologist
My cancer affects bones that support my weight or bones that do not.
+8 more
Exclusion Criteria
I have had radiotherapy or surgery to relieve pain in a specific area.
I have spinal cord compression from cancer spread with symptoms beyond pain.
My cancer has not spread to my skull, hands, or feet.
Participant Groups
The study tests if palliative radiation therapy can reduce bone metastasis-related pain in cancer patients. It involves external beam radiation therapy aimed at easing symptoms and improving quality of life through a randomized phase II trial design.
2Treatment groups
Experimental Treatment
Group I: ARM II (palliative radiation therapy)Experimental Treatment4 Interventions
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
Group II: ARM I (palliative radiation therapy)Experimental Treatment4 Interventions
Patients undergo 1 fraction of EBRT over 30 minutes.
Palliative Radiation Therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as Zepzelca for:
- Metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator