Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Purpose

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	Intervention	Phase
Prostate Cancer	Procedure: radiation therapy	Phase I

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Triiodothyronine Liothyronine sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 1991

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002480

Locations


United States, New York
	Memorial Sloan-Kettering Cancer Center
	New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators


Study Chair:	Michael J. Zelefsky, MD	Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

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.

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. Review. 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.

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;1(2):142.

Study ID Numbers:	CDR0000077099, MSKCC-91022, NCI-V91-0102
First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002480
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate

stage II prostate cancer

stage III prostate cancer

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Adenocarcinoma

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002480