|Phase III||Supportive care||Completed||18 and over||NCI, Other||CDR0000065957|
RTOG-9714, NCCTG-R9714, NCI-P97-0124, NCT00003162
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective for bone metastases.
PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer.
Further Study Information
- Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer.
- Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations.
- Compare the effect on quality of life of these two treatments in these patient populations.
- Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations.
OUTLINE: This is a randomized study.
Patients are assigned to 1 of 2 treatment arms. Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks. Arm II consists of a single dose of radiation therapy. Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score.
Patients are followed and quality of life is assessed at 2 and 4 weeks, then at 2, 3, 6, 9, and 12 months, every 6 months for the next 3 years, then annually until death.
PROJECTED ACCRUAL: This study will accrue 938 patients within 2 years.
- Histologically proven breast or prostate cancer
- Radiographic evidence of bone metastasis within 8 weeks of study
- Eligible treatment sites:
- Weight bearing sites:
- Pelvis (excluding pubis)
- Sacrum and/or sacroiliac joints
- Nonweight bearing sites:
- Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
- Lumbosacral spine
- Up to 3 consecutive ribs
- Radius with/without ulna
- If multiple sites are treated, site is included as weight bearing if any of the sites include the pelvis, sacrum, femur, or tibia
- Worst pain score of at least 5 on a scale of 10
- No skull, feet, or hand metastases
- No spinal cord or cauda equina compression/effacement in vertebral metastases
- Multiple sites eligible if they can be included in no greater than 3 treatment sites
- 18 and over
- Karnofsky 40-100%
- At least 3 months
- Not specified
- Not specified
- Not specified
- No impending fracture of the treatment site
- No hematologic primary malignancies
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- No change in immunotherapy within 30 days
- No change in chemotherapy within 30 days
- No change in hormonal therapy within 30 days
- No prior radiation therapy to treatment area
- At least 30 days since systemic radiotherapy (Sr 89)
- No prior palliative surgery to treatment area
- No planned surgical fixation of the bone
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology GroupNational Cancer Institute
North Central Cancer Treatment Group
|William F. Hartsell||Study Chair|
|Ivy A. Petersen||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003162
Information obtained from ClinicalTrials.gov on November 20, 2012
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