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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003162 |
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 III |
| 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:
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:
Eligible treatment sites:
Weight bearing sites:
Nonweight bearing sites:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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
| 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 |
|
stage IV breast cancer recurrent breast cancer stage IV prostate cancer |
recurrent prostate cancer bone metastases pain |
|
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 |