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Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer Clinical research trials and Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer  Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
For Condition: stage 4 prostate cancer,stage 3 prostate cancer,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
Details: OBJECTIVES: - Compare the efficacy, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide in patients with localized high-risk prostate cancer. - Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are stratified according to PSA (no greater than 10 vs greater than 10), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms. All patients receive androgen suppression consisting of goserelin OR leuprolide AND bicalutamide OR flutamide for 4 months. All patients also undergo radiotherapy beginning 8 weeks after the initiation of androgen suppression for 5 days a week for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy. - Arm I: Patients continue androgen suppression therapy for about 20 more months (goserelin or leuprolide only) after radiotherapy is completed. - Arm II: Patients continue therapy as in arm I, plus receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy consists of oral estramustine 3 times a day and oral etoposide twice a day on days 1-14 plus paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1440 patients will be accrued for this study within 6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven prostate cancer at high risk for relapse as determined by either: - PSA 20-100 and Gleason score at least 7 (any T stage) OR - Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 - Negative lymph nodes - No metastatic disease PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Zubrod 0 or 1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 130,000/mm^3 - Hemoglobin at least 11.4 g/dL Hepatic: - AST no greater than 2 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL Other: - No other prior or concurrent invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer - No major medical or psychiatric illness that would preclude study participation - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 5 years since prior chemotherapy Endocrine therapy: - At least 60 days since prior finasteride for prostatic hypertrophy - At least 90 days since prior testosterone - No greater than 30 days since start of prior pharmacologic androgen ablation for prostate cancer Radiotherapy: - No prior pelvic radiotherapy Surgery: - No prior radical prostatectomy - No prior cryosurgery for prostate cancer - No prior orchiectomy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardSandler, Study Chair, University of Michigan Comprehensive Cancer Center
Sutter Health Western Division Cancer Research Group *Recruiting*
Greenbrae, California, 94904
United States
Recruiting David Irwin 415-925-7916
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Mount Diablo Medical Center *Recruiting*
Concord, California, 94524-4110
United States
Recruiting Daniel Chinn 925-674-2521
Greater Baltimore Medical Center and Cancer Center *Recruiting*
Baltimore, Maryland, 21204
United States
Recruiting Robert Brookland 443-849-2540
Methodist Cancer Center at Methodist Hospital *Recruiting*
Indianapolis, Indiana, 46206-1367
United States
Recruiting Peter Garrett 317-926-3172
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting David Schwartz 206-768-5356
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Barbara Fisher 519-685-8650
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Sophie Turner 516-562-4815
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Mark Bryer 573-882-2100
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Lutheran General Cancer Care Center *Recruiting*
Park Ridge, Illinois, 60068
United States
Recruiting John Chang 847-723-8030
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting John Carson 506-648-6884
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Benjamin Movsas 215-728-3631
Anne Arundel Oncology Center *Recruiting*
Annapolis, Maryland, 21401
United States
Recruiting Angel Torano 443-481-5800
Mary Bird Perkins Cancer Center *Recruiting*
Baton Rouge, Louisiana, 70809
United States
Recruiting Kenneth Lo 225-767-0847
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Peter Schiff 212-305-8096
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Reinhard Gahbauer 614-293-8415
Marquette General Hospital *Recruiting*
Marquette, Michigan, 49855
United States
Recruiting Paul Thieme 906-225-3102
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
St. Luke's Medical Center *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting Mitchell Pincus 414-649-6420
Akron General Medical Center *Recruiting*
Akron, Ohio, 44302
United States
Recruiting Mitchell Fromm 330-296-5019
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Elizabeth Gore 414-805-4465
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Thomas Saphner 920-432-5134
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Albert DeNittis 610-645-2433
Fox Chase Cancer Center at St. Francis Medical Center *Recruiting*
Trenton, New Jersey, 08629
United States
Recruiting Jo Chalal 609-599-5179
St. Vincent Hospital *Recruiting*
Green Bay, Wisconsin, 54307-3508
United States
Recruiting Gregory Cooley 414-433-8184
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Leonard Gomella 215-955-6963
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Jay Joseph 707-525-1150
All Saints Cancer Center at All Saints Healthcare *Recruiting*
Racine, Wisconsin, 53405
United States
Recruiting James Taylor 262-687-5000
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Ruby Meredith 205-934-4763
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Paul Sperduto 952-993-1517
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Ritsuko Komaki 713-563-2328
Albert Einstein Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19141-3098
United States
Recruiting Sucha Asbell 215-456-6280
Delaware County Memorial Hospital *Recruiting*
Drexel Hill, Pennsylvania, 19026
United States
Recruiting Rachelle Lanciano 610-284-8240
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Rachel Rabinovitch 720-848-0116
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
South Jersey Regional Cancer Center *Recruiting*
Millville, New Jersey, 08332
United States
Recruiting Joseph Fanelle 856-293-2910
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting Lawrence Berk 614-566-9506
Ball Memorial Hospital Cancer Center *Recruiting*
Muncie, Indiana, 47303-3499
United States
Recruiting Anthony Tilmans 765-747-3827
St. Luke's Hospital Cancer Center *Recruiting*
Bethlehem, Pennsylvania, 18015
United States
Recruiting Nimisha Deb 610-954-4300
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0010
United States
Recruiting Howard Sandler 734-936-9338
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Raul Meoz-Mendez 702-384-0013
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0293
United States
Recruiting Mohammed Mohiuddin 859-323-6489
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital *Recruiting*
Allentown, Pennsylvania, 18105
United States
Recruiting Victor Risch 610-402-0700
Atlantic City Medical Center *Recruiting*
Pomona, New Jersey, 08240
United States
Recruiting Jorge Cassir 609-652-3417
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
Wellspan Health - York Cancer Center *Recruiting*
York, Pennsylvania, 17403
United States
Recruiting Ronald Malcom 717-741-8100
Additional Information:
Study ID Numbers: CDR0000067250; RTOG-9902,CTSU,RTOG-DEV-1020
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004054
Other Stage 4 Prostate Cancer Studies:
1. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
2. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
4. Neoadjuvant Thalidomide in Treating Patients With Locally Advanced Prostate Cancer Who Are Undergoing Radical Prostatectomy
5. Diet and PSA Levels in Patients With Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Ohio Clinical Trials
Other Dayton Clinical Trials
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
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