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Radiation Therapy

Palliative Radiation Therapy for Bone Metastasis

N/A
Waitlist Available
Led By Doris R Brown
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of cancer, not including multiple myeloma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
Must not have
Previous radiotherapy or palliative surgery to the painful site
Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how radiation therapy can ease pain in cancer patients with bone metastasis. External beam radiation may help reduce their symptoms and pain.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Palliative radiation may cause side effects like skin irritation where treated, fatigue, mild swelling around treatment areas, and temporary increase in pain before relief sets in (pain flare). Long-term effects might include weakened bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with cancer, but not multiple myeloma.
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I can care for myself but may not be able to do heavy physical work.
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My pain level is at least 5 out of 10, or I take a strong painkiller daily.
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I can be treated for bone issues in up to three places.
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My doctor has decided I need radiation therapy for symptom relief.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiotherapy or surgery to relieve pain in a specific area.
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I have spinal cord compression from cancer spread with symptoms beyond pain.
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My cancer has not spread to my skull, hands, or feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Re-Treatment rRates
Secondary study objectives
Change in Pain Intensity/Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS)
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) core(C)15-palliative (PAL)
Incidence of Adverse Events
+3 more

Side effects data

From 2021 Phase 3 trial • 926 Patients • NCT01414608
79%
Fatigue
76%
Nausea
73%
Diarrhea
71%
Lymphocyte count decreased
65%
Anemia
36%
Vomiting
35%
Abdominal pain
31%
Vaginal discharge
31%
Platelet count decreased
28%
Pelvic pain
26%
Neutrophil count decreased
24%
Peripheral sensory neuropathy
22%
General disorders NOS
20%
Cystitis noninfective
17%
Alanine aminotransferase increased
16%
Pain in extremity
14%
Dermatitis radiation
12%
Creatinine increased
12%
Dehydration
11%
Vaginal pain
10%
Myalgia
10%
Hemorrhage Bladder
9%
Aspartate aminotransferase increased
9%
Hearing impaired
8%
Proctitis
8%
Vaginal dryness
8%
Alopecia
7%
Hemorrhage Rectum
7%
Vaginal stricture
6%
Mucositis oral
6%
Thrombosis/Thrombus/Embolism
6%
Urinary tract pain
4%
Allergic reaction/ hypersensitivity
4%
Rectal pain
3%
Anal pain
3%
Colitis
3%
Lymphedema
2%
Perineal pain
2%
Telangiectasia
2%
Enterocolitis
2%
Febrile neutropenia
2%
Female genital tract fistula
2%
Peripheral motor neuropathy
2%
Tumour pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Chemoradiation
Standard Chemoradiation With Adjuvant Chemotherapy

Awards & Highlights

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

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Palliative Radiation Therapy
2015
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,233 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,478 Total Patients Enrolled
Doris R BrownPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Palliative Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02699697 — N/A
Bone Metastasis Research Study Groups: ARM I (palliative radiation therapy), ARM II (palliative radiation therapy)
Bone Metastasis Clinical Trial 2023: Palliative Radiation Therapy Highlights & Side Effects. Trial Name: NCT02699697 — N/A
Palliative Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02699697 — N/A
~11 spots leftby Dec 2025
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