Radiation Therapy in Treating Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002480|
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : June 25, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: radiation therapy||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D) conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II. Determine the morbidity of high-dose 3D conformal therapy in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate|
|Study Start Date :||February 1991|
|Primary Completion Date :||August 2005|
|Study Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002480
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Michael J. Zelefsky, MD||Memorial Sloan Kettering Cancer Center|