Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00002480
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1991-02-28
2005-08-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.
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Detailed Description
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OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No metallic pelvic prosthesis
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior radiotherapy (including pelvic irradiation) Surgery: No prior radical surgery for carcinoma of the prostate
18 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Michael J. Zelefsky, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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References
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Leibel SA, Heimann R, Kutcher GJ, Zelefsky MJ, Burman CM, Melian E, Orazem JP, Mohan R, LoSasso TJ, Lo YC, et al. Three-dimensional conformal radiation therapy in locally advanced carcinoma of the prostate: preliminary results of a phase I dose-escalation study. Int J Radiat Oncol Biol Phys. 1994 Jan 1;28(1):55-65. doi: 10.1016/0360-3016(94)90141-4.
Leibel SA, Zelefsky MJ, Kutcher GJ, Burman CM, Kelson S, Fuks Z. Three-dimensional conformal radiation therapy in localized carcinoma of the prostate: interim report of a phase 1 dose-escalation study. J Urol. 1994 Nov;152(5 Pt 2):1792-8. doi: 10.1016/s0022-5347(17)32387-x.
Leibel SA, Zelefsky MJ, Kutcher GJ, Burman CM, Mohan R, Mageras GS, Ling CC, Fuks Z. The biological basis and clinical application of three-dimensional conformal external beam radiation therapy in carcinoma of the prostate. Semin Oncol. 1994 Oct;21(5):580-97. No abstract available.
Zelefsky MJ, Leibel SA, Burman CM, Kutcher GJ, Harrison A, Happersett L, Fuks Z. Neoadjuvant hormonal therapy improves the therapeutic ratio in patients with bulky prostatic cancer treated with three-dimensional conformal radiation therapy. Int J Radiat Oncol Biol Phys. 1994 Jul 1;29(4):755-61. doi: 10.1016/0360-3016(94)90563-0.
Zelefsky MJ, Leibel SA, Kutcher GJ, Kelson S, Ling CC, Fuks Z. The feasibility of dose escalation with three-dimensional conformal radiotherapy in patients with prostatic carcinoma. Cancer J Sci Am. 1995 Jul-Aug;1(2):142-50.
Other Identifiers
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CDR0000077099
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-V91-0102
Identifier Type: -
Identifier Source: secondary_id
91-022
Identifier Type: -
Identifier Source: org_study_id
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