Malignant NeoplasmNCT02699697
Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis
A study testing External Beam Radiation Therapy, Palliative Radiation Therapy and Quality-of-Life Assessment in people with Malignant Neoplasm and Metastatic Malignant Neoplasm in the Bone, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone, Pain
- What is being tested?
- External Beam Radiation Therapy, Palliative Radiation Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of cancer, not including multiple myeloma
- Radiographic evidence of bone metastases within 8 weeks of study; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites
- Eligible treatment sites are:
- Weight bearing sites
- Pelvis (excluding pubis)
- Femur
Show all 26Show fewer
- Sacrum and/or sacroiliac joints
- Tibia
- Non-weight bearing sites
- Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies
- Lumbosacral spine
- Up to 3 consecutive ribs
- Humerus
- Fibula
- Radius ± ulna
- Clavicle
- Sternum
- Scapula
- Pubis If multiple sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur or tibia
- Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain score < 5 with >= 60 mg of morphine (or equivalent) per day
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
- Negative pregnancy test at study registration
- Changes in systemic chemotherapy, hormonal therapy or the use of bisphosphonates for 4 weeks before and after the delivery of radiotherapy are allowed, but recording and accounting for this in the statistical analysis is required
- Life expectancy of at least 12 weeks as deemed by the treating oncologist
- Patients will be eligible for treatment of multiple osseous sites only if those sites can be included in no more than three treatment sites; for patients with painful metastases that are contiguous but do not fit into the definition of a site listed above, those patients will still be eligible but will be considered to have two treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be eligible but would be considered as two treatment sites since more than five consecutive vertebral bodies would be treated; these lesions could be treated with one field, even though the treatment is coded as two sites
Who cannot join
- Previous radiotherapy or palliative surgery to the painful site
- Metastases to the skull, hands, feet are not eligible treatment sites
- Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Prospective Randomized Phase II Study of 1 vs 2 Fractions of Palliative Radiation Therapy for Patients With Symptomatic Bone Metastasis
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction.
SECONDARY OBJECTIVES:
- To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief compared to 8 Gy x 1 fraction.
II. To determine whether 8 Gy x 2 fractions is associated with improved quality of life compared to 8 Gy x 1 fraction.
III. To determine whether use of a bone strengthening agent is associated with improved pain relief, narcotic relief and re-treatment rates.
IV. To determine if 8 Gy x 2 fractions is associated with increased toxicity. V. To correlate patient satisfaction, perceived stress, and social support with treatment outcomes.
TERTIARY OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 1 fraction of external beam radiation therapy (EBRT) over 30 minutes.
ARM II: Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
After completion of study treatment, patients are followed up at 30 days and at 3 months.
- Being tested
- External Beam Radiation Therapy, Palliative Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT
Undergo EBRT
Palliative Radiation TherapyRadiation
Undergo EBRT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| ARM I (palliative radiation therapy) | Experimental | Patients undergo 1 fraction of EBRT over 30 minutes. Receives: Radiation: External Beam Radiation Therapy; Radiation: Palliative Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| ARM II (palliative radiation therapy) | Experimental | Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. Receives: Radiation: External Beam Radiation Therapy; Radiation: Palliative Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)
The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.
Measured: Up to 6 months post-treatment
Secondary outcomes (7)
Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale
Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion.
Measured: At 3 months and 6 months post-treatment
Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use
Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion.
The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. The rating pain scale is from 0-10, with 0 being no pain, 8-10 worst possible pain.
Measured: At 3 months and 6 months post-treatment
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Analyses will be performed that examine whether there are associations between quality of life and treatment outcome (re-treatment rates or amount of pain relief). Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Either multiple logistic regression (for binary outcomes) models or analysis of covariance (ANCOVA) models for continuous outcomes will be used. The QLQ-C15-PAL has high sensitivity and specificity for identifying clinically important symptoms and functional health impairments. Scores range from 0 to 100 with higher values indicating a better quality of life in the Physical and Emotional Functioning and Quality of Life categories. Higher scores in Symptoms Scales categories indicates a worse quality of life. Most questions are rated on a 4-point Likert scale (1 = not at all to 4 = very much), but the global quality of life item uses a 7-point scale (1 = very poor to 7 = excellent)
Measured: At 3 months and 6 months post-treatment
Incidence of Adverse Events - Grade 3 or Higher
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Groups will be compared to determine whether there are any differences in the number or severity of toxicities. When comparing severity of toxicities between groups, chi-square tests will be examined. The Cochran-Armitage trend test can be used to determine if there is evidence a trend in severity of toxicities when comparing groups. Because of the patient population as well as the treatment, emphasis will be placed on gastrointestinal (GI disturbance, esophagitis, diarrhea, nausea, and vomiting), hematological (low blood counts or bleeding), spinal (bone fracture, compression fracture, insufficiency, or myelitis), and pulmonary toxicities (pneumonitis) and recorded by clinical research coordinators. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to the event.
Measured: Up to 6 months post-treatment
Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)
Analyses will be performed that examine whether there are associations between patient satisfaction and treatment outcome (re-treatment rates or amount of pain relief). Satisfaction will be measured by answering a series of questions with a scoring scale range of 1 (strongly agree) to 5 (strongly disagree). The scoring range for the Patient Satisfaction with Cancer Care (PSCC)-18 is 18 (best score) to 90 (worse score). A lower total score indicates higher satisfaction with cancer care.
Measured: At 3 months and 6 months post-treatment
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS) is a stress assessment instrumentto help understand how different situations affect feelings and perceived stress. Scoring scale is 1 (never) to 4 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced. The Perceived Stress Scale (PSS-10) is scored by summing the responses to all 10 items, with a total score ranging from 0 to 40. To get the score, you first need to reverse the scoring for the positively worded items (items 4, 5, 7, and 8). A total score of 0-13 suggests low stress, 14-26 indicates moderate stress, and 27-40 represents high stress.
Perceived helplessness (items 1, 2, 3, 6, 9, 10) - measuring an individual's feelings of a lack of control over their circumstances or their own emotions or reactions.
Lack of self-efficacy (items 4, 5, 7, 8) - measuring an individual's perceived inability to handle problems.
Measured: At 3 months and 6 months post-treatment
Participants With Social Support Assessed Via Self-Reported Surveys
Association between social support and treatment outcomes will be assessed. Social support will be measured by answering a series of questions with a scoring scale range of 1 (definitely false for you) to 4 (definitely true for you). The total score is the sum of all items, ranging from 0 to 36. Sum the scores for the four items in each subscale (Appraisal, Belonging, and Tangible) to get a score ranging from 0 to 12 for each subscale. The higher the total score the more support the participants receive from their support network.
Measured: At 3 months and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Doris R Brown, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699697
- Sponsor's protocol ID
- IRB00037248
- Other IDs
- NCI-2016-00204, CCCWFU 01416, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2016
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Phase II Study of 1 vs 2 Fractions of Palliative Radiation Therapy for Patients With Symptomatic Bone Metastasis
- ClinicalTrials.gov ID
- NCT02699697
- Acronym / sponsor ID
- IRB00037248
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2016
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction.
SECONDARY OBJECTIVES:
- To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief compared to 8 Gy x 1 fraction.
II. To determine whether 8 Gy x 2 fractions is associated with improved quality of life compared to 8 Gy x 1 fraction.
III. To determine whether use of a bone strengthening agent is associated with improved pain relief, narcotic relief and re-treatment rates.
IV. To determine if 8 Gy x 2 fractions is associated with increased toxicity. V. To correlate patient satisfaction, perceived stress, and social support with treatment outcomes.
TERTIARY OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 1 fraction of external beam radiation therapy (EBRT) over 30 minutes.
ARM II: Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
After completion of study treatment, patients are followed up at 30 days and at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (palliative radiation therapy) | Experimental | Radiation: External Beam Radiation Therapy, Radiation: Palliative Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo 1 fraction of EBRT over 30 minutes. |
| ARM II (palliative radiation therapy) | Experimental | Radiation: External Beam Radiation Therapy, Radiation: Palliative Radiation Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Diagnosis of cancer, not including multiple myeloma
- Radiographic evidence of bone metastases within 8 weeks of study; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites
- Eligible treatment sites are:
- Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain score < 5 with >= 60 mg of morphine (or equivalent) per day
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
Key exclusion criteria (3 listed)
- Previous radiotherapy or palliative surgery to the painful site
- Metastases to the skull, hands, feet are not eligible treatment sites
- Spinal cord or cauda equine compression/effacement in vertebral metastases with neurological symptoms other than just pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RTUndergo EBRT | Radiation | ARM I (palliative radiation therapy), ARM II (palliative radiation therapy) |
| Palliative Radiation TherapyUndergo EBRT | Radiation | ARM I (palliative radiation therapy), ARM II (palliative radiation therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | ARM I (palliative radiation therapy), ARM II (palliative radiation therapy) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (palliative radiation therapy), ARM II (palliative radiation therapy) |
Primary outcome
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)
Time frame: Up to 6 months post-treatment
The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.
7 secondary outcomes
Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale
Time frame: At 3 months and 6 months post-treatment
Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use
Time frame: At 3 months and 6 months post-treatment
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Time frame: At 3 months and 6 months post-treatment
Incidence of Adverse Events - Grade 3 or Higher
Time frame: Up to 6 months post-treatment
Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)
Time frame: At 3 months and 6 months post-treatment
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Time frame: At 3 months and 6 months post-treatment
Participants With Social Support Assessed Via Self-Reported Surveys
Time frame: At 3 months and 6 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris R Brown principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Beam Radiation Therapy, Palliative Radiation Therapy and Quality-of-Life Assessment in people with Malignant Neoplasm and Metastatic Malignant Neoplasm in the Bone, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) (time frame: Up to 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.