Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

Not Applicable

Active, not recruiting

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

• Registration Number: NCT02699697
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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). 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:

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 Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-04
• Study Start: 2016-05
• Primary Completion: 2024-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-18
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM II (palliative radiation therapy)	Palliative Radiation Therapy	Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
ARM I (palliative radiation therapy)	Palliative Radiation Therapy	Patients undergo 1 fraction of EBRT over 30 minutes.
ARM II (palliative radiation therapy)	Quality-of-Life Assessment	Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
ARM I (palliative radiation therapy)	Quality-of-Life Assessment	Patients undergo 1 fraction of EBRT over 30 minutes.
ARM I (palliative radiation therapy)	External Beam Radiation Therapy	Patients undergo 1 fraction of EBRT over 30 minutes.
ARM I (palliative radiation therapy)	Questionnaire Administration	Patients undergo 1 fraction of EBRT over 30 minutes.
ARM II (palliative radiation therapy)	External Beam Radiation Therapy	Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
ARM II (palliative radiation therapy)	Questionnaire Administration	Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.

Primary Outcome Measures

Name	Time	Method
Re-Treatment rRates	Up to 6 months post-treatment	The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Intensity/Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS)	Baseline to up to 6 months post-treatment	Measured on a continuous scale and will be compared between groups using 2-sample t-tests.; The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. Patients categorized as Complete or Partial Responders will be compared with those categorized as stable or worsening pain responders. The rating pain scale is from 0-10, with 0 being no pain 8-10 worst possible pain.
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) core(C)15-palliative (PAL)	Baseline to up to 6 months post-treatment	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.
Incidence of Adverse Events	Up to 6 months post-treatment	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.
Number of Participants with Patient Satisfaction of Treatment Outcome	Up to 6 months post-treatment	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 higher the total score the less satisfaction with treatment received.
Number Participants with Perceived Stress of Treatment Outcome	Up to 6 months post-treatment	Analyses will be performed that examine whether there are associations between perceived stress measures and treatment outcome (re-treatment rates or amount of pain relief). Scoring scale is 1 (never) to 5 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced.
Number of Participants with Social Support Assessed Via Self-Reported Surveys	Up to 6 months post-treatment	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 higher the total score the more support the participants receive from their support network.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States