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Radiation Therapy in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002480   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
February 1991
 
 
 
Complete list of historical versions of study NCT00002480 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy in Treating Patients With Prostate Cancer
Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate

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.

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.

Phase I
Interventional
Treatment
Prostate Cancer
Radiation: radiation therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS: Locally advanced (T2c-T3) adenocarcinoma of the prostate including: Bulky tumors confined to prostate (stage II) Tumors extending beyond capsule (stage III) PSA no greater than 20 ng/mL No regional lymph node involvement (by CT scan or surgical sampling) No distant metastases

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002480
 
CDR0000077099, MSKCC-91022, NCI-V91-0102
Memorial Sloan-Kettering Cancer Center
 
Study Chair: Michael J. Zelefsky, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP