|
||||||||||||||||||||||
|
|
Phase III Randomized Study of Palliative Radiation Therapy for Bone Metastases From Breast or Prostate Cancer
Alternate Title Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment 938This study will accrue 938 patients within 2 years. 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. Published ResultsHartsell WF, Desilvio M, Bruner DW, et al.: Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 97-14. J Palliat Med 11 (5): 723-8, 2008.[PUBMED Abstract] Konski A, Desilvio M, Hartsell W, et al.: Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys 66 (1): 229-33, 2006.[PUBMED Abstract] Hartsell WF, Scott CB, Bruner DW, et al.: Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst 97 (11): 798-804, 2005.[PUBMED Abstract] Hartsell WF, Winter K, Bruner DW, et al.: Breast cancer patients have better outcomes than prostate cancer patients for palliation of painful bone metastases: results of RTOG 97-14. [Abstract] J Clin Oncol 23 (Suppl 16): A-6073, 546s, 2005. Bruner DW, Winter K, Hartsell W, et al.: Prospective health-related quality of life valuations (utilities) of 8 Gy in 1 fraction vs 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97–14. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-23, S142, 2004. Hartsell WF, DeSilvio M, Bruner DW, et al.: Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-25, S143, 2004. Hartsell WF, Scott C, Bruner DW, et al.: Phase III randomized trial of 8 Gy in 1 fraction vs. 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S124, 2003. Related PublicationsBruner DW: Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr (37): 12-5, 2007.[PUBMED Abstract] Juliano JJ, Reddy CA, Videtic GMM: How fast does practice change? A single-institution experience in utilization of a single fraction for palliation of bone metastases before and after RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2561, S521-2, 2006. Trial Lead Organizations Radiation Therapy Oncology Group
North Central Cancer Treatment Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |