Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastatic Cancer Pain Prostate Cancer |
Procedure: pain therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life |
| Estimated Enrollment: | 938 |
| Study Start Date: | February 1998 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Nonweight 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
Contacts and Locations
Show 253 Study Locations| Study Chair: | William F. Hartsell, MD | Lutheran General Hospital |
| Study Chair: | Ivy A. Petersen, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003162 History of Changes |
| Other Study ID Numbers: | CDR0000065957, RTOG-9714, NCCTG-R9714, NCI-P97-0124 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 29, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer recurrent breast cancer stage IV prostate cancer |
recurrent prostate cancer bone metastases pain |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplasms by Site Breast Diseases |
Skin Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013