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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
Breast Cancer Metastatic Cancer Pain Prostate Cancer |
Procedure: pain therapy Procedure: radiation therapy |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Prostate Cancer |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
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 |
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.
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:
Show 253 Study Locations |
Radiation Therapy Oncology Group |
National Cancer Institute (NCI) |
North Central Cancer Treatment Group |
Study Chair: | William F. Hartsell, MD | Lutheran General Hospital |
Study Chair: | Ivy A. Petersen, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Hartsell WF, Desilvio M, Bruner DW, Scarantino C, Ivker R, Roach M, Suh J, Demas WF, Movsas B, Petersen IA, Konski AA. Can Physicians Accurately Predict Survival Time in Patients with Metastatic Cancer? Analysis of RTOG 97-14. J Palliat Med. 2008 Jun;11(5):723-8.
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Konski A, Desilvio M, Hartsell W, Watkins-Bruner D, Coyne J, Scarantino C, Janjan N. Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):229-33. Epub 2006 Jul 11.
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Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804.
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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.
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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.
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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.
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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.
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Bruner DW. Outcomes Research in Cancer Symptom Management Trials: The Radiation Therapy Oncology Group (RTOG) Conceptual Model. J Natl Cancer Inst Monogr. 2007;(37):12-5.
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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.
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Study ID Numbers: | CDR0000065957, RTOG-9714, NCCTG-R9714, NCI-P97-0124 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003162 |
Health Authority: | United States: Federal Government |
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