Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

Phase III DES or Orchiectomy vs CTX/5-FU plus DES or Orchiectomy vs Estracyt for Stage D2 Prostate Cancer without Prior Endocrine Therapy or Chemotherapy

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

no age specified

NPCTG-1300

Objectives

I.  Compare diethylstilbestrol or orchiectomy vs. 
cyclophosphamide/5-fluorouracil plus diethylstilbestrol or orchiectomy vs. 
estracyt in the treatment of newly diagnosed patients with clinical Stage D 
carcinoma of the prostate who have not previously been treated with 
chemotherapy or endocrine therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed cancer of the prostate diagnosed within 30 days of randomization who 
have bone or demonstrable soft tissue metastases that are Stage D2.  The 
expected survival must be at least 90 days, and bone marrow function must be 
adequate.  Patients must have recovered from the effects of major surgery and 
be free from significant infection.  There may have been no prior chemotherapy 
or hormonal therapy, nor may there be present another malignancy (with the 
exception of nonmelanomatous skin tumors).

Expected Enrollment

333 patients will be entered.  Protocol closed in 1985.

Outline

Randomized study.
Arm I:  Hormone Therapy.  Diethylstilbestrol, DES, NSC-3070; or Orchiectomy.
Arm II:  2-Drug Combination Chemotherapy plus Hormone Therapy.  
Cyclophosphamide, CTX, NSC-26271; 5-Fluorouracil, 5-FU, NSC-19893; plus DES or 
Orchiectomy.
Arm III:  Single-agent Chemotherapy.  Estracyt, ESC, NSC-89199.

Trial Contact Information

Trial Lead Organizations

National Prostate Cancer Treatment Group

Gerald P. Murphy, MD, Protocol chair(Contact information may not be current)
Ph: 206-368-3094

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.