Palliative Radiation Therapy for Bone Metastasis

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing palliative radiation therapy to evaluate its effectiveness in reducing pain for cancer patients with bone metastases. Participants will receive varying doses of external beam radiation therapy, which uses high-energy rays to target cancer cells, to determine the most effective approach for pain relief. The trial seeks participants with cancer that has spread to specific bones, causing significant pain, who have not undergone previous radiation or surgery at the painful site. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance pain management for future patients.

Do I need to stop my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. However, changes in systemic chemotherapy, hormonal therapy, or bisphosphonates are allowed 4 weeks before and after the radiotherapy, but these changes must be recorded for analysis.

What prior data suggests that palliative radiation therapy is safe for patients with bone metastasis?

Research has shown that palliative radiation therapy is a well-established and safe method for managing pain from cancer that has spread to the bones. Studies have found that this treatment effectively reduces pain for many patients, with about 60% experiencing relief within two to three weeks after treatment.

Regarding safety, external beam radiation therapy (EBRT) is commonly used and considered safe. One study found that a single dose of radiation, measured as 8 Gy, effectively relieves pain. While some side effects may occur, they are usually mild and manageable.

It is important to note that while palliative radiation therapy effectively eases pain, it does not treat the cancer itself. Instead, it focuses on reducing pain and improving the patient's quality of life. Overall, research supports palliative radiation therapy as a safe option for patients dealing with pain from cancer in the bones.12345

Why are researchers excited about this trial?

Researchers are excited about using palliative radiation therapy for bone metastasis because it offers a potentially quicker and more convenient treatment option. Unlike traditional radiation therapy, which often requires multiple sessions, this approach tests the effectiveness of just one or two sessions of external beam radiation therapy (EBRT). For patients, this means fewer trips to the hospital and less disruption to their daily lives. Additionally, the shorter, more intense treatment schedule might provide rapid pain relief, addressing one of the most significant challenges faced by individuals with bone metastasis.

What evidence suggests that palliative radiation therapy is effective for reducing pain in bone metastasis?

Studies have shown that palliative radiation therapy effectively reduces pain for patients with cancer that has spread to the bones. About 60% of patients experience pain relief within 2 to 3 weeks after treatment. Research indicates that this relief lasts a reasonable amount of time, aiding in better symptom management. In this trial, participants will receive external beam radiation therapy (EBRT) in one of two treatment arms: one arm involves a single fraction of EBRT, while the other involves two fractions separated by 3-7 days. This treatment is widely used and considered reliable for improving the quality of life in patients with bone metastases.12367

Who Is on the Research Team?

DR

Doris R Brown

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.
See 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: ARM II (palliative radiation therapy)Experimental Treatment4 Interventions
Group II: ARM I (palliative radiation therapy)Experimental Treatment4 Interventions

Palliative Radiation Therapy is already approved in United States for the following indications:

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Approved in United States as Zepzelca for:

Find a Clinic Near You

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+

Citations

Palliative Radiation Therapy For Bone Metastases - NCBI - NIHAfter treatment, most patients will expect to experience pain relief in 2 to 3 weeks in 60% of patients.[13][14] The indications for palliative ...
External Beam Radiation Therapy for Palliation of ...Radiation therapy for the management of painful bone metastases: Results from a randomized trial. Rep Pract Oncol Radiother. 2014; 19:405-411.
Radiation Therapy for Painful Bone MetastasesIn this review, we summarize data on EBRT outcomes for pain relief from uncomplicated and complicated bone metastases, explore available data on other ...
Evaluation of effectiveness of palliative radiotherapy for ...Palliative radiotherapy in our unselected patients with bone metastases showed similar pain response rates (61%), with a reasonable duration of this effect.
Palliative radiotherapy of bone metastases in octogenariansAt the time of data analysis, 263 of the 288 patients had died. Median OS amounted to 9 months, and 1-year, 2-year and 3-year OS were 43%, 28% ...
Use and Reporting of Patient-Reported Outcomes in Trials ...A 2021 cohort study underlined this aspect, as it reported a 30-day mortality rate of 24% in 518 patients after palliative radiotherapy.
Study protocol: feasibility and safety of conventional ...Bone metastases cause significant pain and functional limitation. Conventional external beam radiotherapy (EBRT) provides effective symptom ...
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