Palliative Radiation Therapy for Bone Metastasis

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Previous radiotherapy, Skull metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

102 Participants Needed

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.

Research Team

Doris R Brown

Principal Investigator

Wake Forest University Health Sciences

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo palliative radiation therapy with either 1 or 2 fractions of external beam radiation therapy (EBRT) over 30 minutes

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person) at 30 days and 3 months

Treatment Details

Interventions

• Palliative Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: ARM II (palliative radiation therapy) Experimental Treatment 4 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 Treatment 4 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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+