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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 4, 2000 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | September 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Grade 3 long-term toxicity assessed by NCI CTC v2.0 and RTOG/EORTC Long-Term Toxicity Criteria at 18 months [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Grade 3 long-term toxicity assessed by NCI CTC v2.0 and RTOG/EORTC Long-Term Toxicity Criteria at 18 months | ||||
| Change History | Complete list of historical versions of study NCT00006359 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Biochemical non-evidence of disease (bNED) at 2 or more years after treatment [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Biochemical non-evidence of disease (bNED) at 2 or more years after treatment | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer | ||||
| Official Title ICMJE | Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer | ||||
| Brief Summary | RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks. Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 3 months for 2 years and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination External Beam Radiation and Brachytherapy Boost with Androgen Suppression for Treatment of Intermediate-Risk Prostate Cancer: An Initial Report of Calgb 99809. Int J Radiat Oncol Biol Phys. 2008 Apr 11; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006359 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068228, CALGB-99809 | ||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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