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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091390 |
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Radiation: brachytherapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate |
Estimated Enrollment: | 110 |
Study Start Date: | July 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).
Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over approximately 5-30 minutes either before or after external beam radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Meets one of the following combination criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, California | |
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | |
Inglewood, California, United States, 90301 | |
Providence Saint Joseph Medical Center - Burbank | |
Burbank, California, United States, 91505 | |
Radiological Associates of Sacramento Medical Group, Incorporated | |
Sacramento, California, United States, 95815 | |
United States, Colorado | |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | |
Boca Raton, Florida, United States, 33486 | |
United States, Illinois | |
OSF St. Francis Medical Center | |
Peoria, Illinois, United States, 61637 | |
United States, Maine | |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | |
Scarborough, Maine, United States, 04074 | |
United States, Michigan | |
William Beaumont Hospital - Royal Oak Campus | |
Royal Oak, Michigan, United States, 48073 | |
United States, New Jersey | |
Newark Beth Israel Medical Center | |
Newark, New Jersey, United States, 07112 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, Vermont | |
Fletcher Allen Health Care - University Health Center Campus | |
Burlington, Vermont, United States, 05401 | |
United States, Wisconsin | |
Waukesha Memorial Hospital Regional Cancer Center | |
Waukesha, Wisconsin, United States, 53188 |
Study Chair: | I-Chow J. Hsu, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000382120, RTOG-0321 |
Study First Received: | September 7, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00091390 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |