Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Basic Trial Information
|Phase III||Supportive care||Completed||18 and over||NCI, Other||RTOG-9714|
CDR0000065957, 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
- Non-weight-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 Contact Information
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology Group
- National Cancer Institute
- North Central Cancer Treatment Group
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00003162
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.