Viewing Study NCT00002480



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00002480
Status: COMPLETED
Last Update Posted: 2013-06-25
First Post: 1999-11-01

Brief Title: Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Organization: Memorial Sloan Kettering Cancer Center

Study Overview

Official Title: Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced Stage T2c and T3 Adenocarcinoma of the Prostate
Status: COMPLETED
Status Verified Date: 2013-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000077099 REGISTRY None None
NCI-V91-0102 Registry Identifier PDQ Physician Data Query None