Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

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.

Study Overview

• Status: Completed
• Conditions: Pain; Metastatic Malignant Neoplasm in the Bone; Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: External Beam Radiation Therapy; Radiation: Palliative Radiation Therapy

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction.

SECONDARY OBJECTIVES:

I. 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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
    • 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM I (palliative radiation therapy); Patients undergo 1 fraction of EBRT over 30 minutes.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: External Beam Radiation Therapy; Undergo EBRT; Other Names: EBRT; Definitive Radiation Therapy; External Beam Radiotherapy; External Beam RT; external radiation; External Radiation Therapy; external-beam radiation; Radiation: Palliative Radiation Therapy; Undergo EBRT
Experimental: ARM II (palliative radiation therapy); Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: External Beam Radiation Therapy; Undergo EBRT; Other Names: EBRT; Definitive Radiation Therapy; External Beam Radiotherapy; External Beam RT; external radiation; External Radiation Therapy; external-beam radiation; Radiation: Palliative Radiation Therapy; Undergo EBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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.	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.	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.	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.	At 3 months and 6 months post-treatment

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Doris R Brown, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimated): March 4, 2016

Study Record Updates

• Last Update Posted (Estimated): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neoplasms
• Other Study ID Numbers: IRB00037248; P30CA012197 (U.S. NIH Grant/Contract); NCI-2016-00204 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 01416 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes