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Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699697
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Metastatic Malignant Neoplasm in the Bone Pain Radiation: External Beam Radiation Therapy Radiation: Palliative Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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 Name: 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in narcotic use in daily oral morphine equivalents [ Time Frame: Baseline to up to 3 months post-treatment ]
  2. Change in pain intensity assessed using the Numerical Rating Pain Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 3 months post-treatment ]
    The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699697


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Sharon Averill, RN    336-716-5440      
Principal Investigator: Doris R Brown         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Doris R Brown Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02699697    
Other Study ID Numbers: IRB00037248
NCI-2016-00204 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 01416 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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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:
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Neoplasms