NCT00003162
Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
PHASE3
COMPLETED
NCT00003162
INTERVENTIONAL
Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
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.
DISEASE CHARACTERISTICS:
* 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)
* 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 with/without ulna
* Clavicle
* Scapula
* Pubis
* 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
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 40-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No impending fracture of the treatment site
* No hematologic primary malignancies
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No change in immunotherapy within 30 days
Chemotherapy:
* No change in chemotherapy within 30 days
Endocrine therapy:
* No change in hormonal therapy within 30 days
Radiotherapy:
* No prior radiation therapy to treatment area
* At least 30 days since systemic radiotherapy (Sr 89)
Surgery:
* No prior palliative surgery to treatment area
* No planned surgical fixation of the bone
Breast Cancer
Metastatic Cancer
Pain
Prostate Cancer
- SUPPORTIVE_CARE
-
- Type: PROCEDURE
- Name: pain therapy
- Description:
- Arm Group Labels: 3.0 Gy x 10 fractions in two weeks, 8.0 Gy x 1 fraction
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: 3.0 Gy x 10 fractions in two weeks, 8.0 Gy x 1 fraction
- Radiation Therapy Oncology Group