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Radiation Therapy
Palliative Radiation Therapy for Bone Metastasis
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study 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 belowSelect...
I have been diagnosed with cancer, but not multiple myeloma.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
My pain level is at least 5 out of 10, or I take a strong painkiller daily.
Select...
I can be treated for bone issues in up to three places.
Select...
My doctor has decided I need radiation therapy for symptom relief.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in narcotic use in daily oral morphine equivalents
Change in pain intensity assessed using the Numerical Rating Pain Scale
Change in quality of life measured using the quality of life questionnaire (QLQ) core(C)15-palliative (PAL) and QLQ-C30
+1 moreSide effects data
From 2021 Phase 3 trial • 926 Patients • NCT0141460879%
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
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
~3070
Palliative Radiation Therapy
2015
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,025 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,995 Total Patients Enrolled
Doris R BrownPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer affects bones that support my weight or bones that do not.My pain level is at least 5 out of 10, or I take a strong painkiller daily.I can be treated for bone issues in up to three places.I have bone metastases with pain, confirmed by scans within the last 8 weeks.I have had changes in my cancer treatment plan.I have been diagnosed with cancer, but not multiple myeloma.I can care for myself but may not be able to do heavy physical work.My doctor has decided I need radiation therapy for symptom relief.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.
Research Study Groups:
This trial has the following groups:- Group 1: ARM I (palliative radiation therapy)
- Group 2: ARM II (palliative radiation therapy)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of participants within this research project?
"Yes, the information on clinicaltrials.gov suggests that this medical trial is actively recruiting. It was initially posted on May 1st 2016 and has since been updated as of October 6th 2022. 158 participants are needed to be enrolled from one location only."
Answered by AI
Are there any opportunities to participate in this trial presently?
"Per the listing on clinicaltrials.gov, this medical experiment is looking for volunteers and was first uploaded in May 2016 with its most recent update being made October 2022."
Answered by AI
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