Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT02699697
Collaborator
National Cancer Institute (NCI) (NIH)
158
1
2
76
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: External Beam Radiation Therapy
  • Radiation: Palliative Radiation Therapy
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction.
SECONDARY OBJECTIVES:
  1. To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief compared to 8 Gy x 1 fraction.

  2. To determine whether 8 Gy x 2 fractions is associated with improved quality of life compared to 8 Gy x 1 fraction.

  3. To determine whether use of a bone strengthening agent is associated with improved pain relief, narcotic relief and re-treatment rates.

  4. 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

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Prospective Randomized Phase II Study of 1 vs 2 Fractions of Palliative Radiation Therapy for Patients With Symptomatic Bone Metastasis
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARM I (palliative radiation therapy)

Patients undergo 1 fraction of EBRT over 30 minutes.

Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation: Palliative Radiation Therapy
    Undergo EBRT

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    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.

    Radiation: External Beam Radiation Therapy
    Undergo EBRT
    Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation: Palliative Radiation Therapy
    Undergo EBRT

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in narcotic use in daily oral morphine equivalents [Baseline to up to 3 months post-treatment]

    2. Change in pain intensity assessed using the Numerical Rating Pain Scale [Baseline to up to 3 months post-treatment]

      Measured on a continuous scale and will be compared between groups using 2-sample t-tests.

    3. Change in quality of life measured using the quality of life questionnaire (QLQ) core(C)15-palliative (PAL) and QLQ-C30 [Baseline to up to 3 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.

    4. Re-treatment rates [Up to 3 months post-treatment]

      The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Doris R Brown, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02699697
    Other Study ID Numbers:
    • IRB00037248
    • NCI-2016-00204
    • CCCWFU 01416
    • P30CA012197
    First Posted:
    Mar 4, 2016
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2022