A Prospective Randomized Phase II Study of 1 vs 2 Fractions of Palliative Radiation Therapy for Patients With Symptomatic Bone Metastasis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant Neoplasm
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility 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)
- •Sacrum and/or sacroiliac joints
- •Non-weight bearing sites
- •Up to 5 consecutive cervical, thoracic or lumbar vertebral bodies
- •Lumbosacral spine
- •Up to 3 consecutive ribs
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale(At 3 months and 6 months post-treatment)
- Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use(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)(At 3 months and 6 months post-treatment)
- Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)(At 3 months and 6 months post-treatment)
- Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)(At 3 months and 6 months post-treatment)
- Incidence of Adverse Events - Grade 3 or Higher(Up to 6 months post-treatment)
- Participants With Social Support Assessed Via Self-Reported Surveys(At 3 months and 6 months post-treatment)