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Clinical Trial: Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. It is not yet known which androgen suppression regimen is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two hormone therapy regimens in treating patients with rising PSA levels following radiation therapy for prostate cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adenocarcinoma of the prostate recurrent prostate cancer | Drug: bicalutamide Drug: buserelin Drug: cyproterone Drug: flutamide Drug: goserelin Drug: leuprolide Drug: nilutamide Procedure: ablative endocrine surgery Procedure: antiandrogen therapy Procedure: endocrine therapy Procedure: hormone therapy Procedure: orchiectomy Procedure: releasing factor agonist therapy | Phase III |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Intermittent Versus Continuous Androgen Suppression in Patients With Prostate-Specific Antigen Progression in the Clinical Absence of Distant Metastases After Prior Radiotherapy for Prostate Cancer
Further Study Details:
OBJECTIVES:
- Compare the survival of prostate cancer patients with prostate-specific antigen progression in the clinical absence of distant metastases after prior radical radiotherapy treated with intermittent androgen suppression (IAS) vs continuous androgen deprivation (CAD).
- Compare the time to the development of hormone resistance in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the serum cholesterol and HDL/LDL levels at 3 years with those at baseline and compare them annually in patients treated with these regimens.
- Evaluate the duration of treatment and non-treatment intervals, time to testosterone recovery (return to pre-therapy levels), and time to recover potency in patients treated with IAS.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior radical prostatectomy (yes vs no), time since completion of prior radical radiotherapy (1 to 3 years vs 3 years or more), baseline prostate-specific antigen (PSA) value (3-15 ng/mL vs greater than 15 ng/mL), and prior hormonal therapy (neo-adjuvant, concurrent, or adjuvant cytoreduction in association with the radical radiotherapy treatment or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization) (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo intermittent androgen suppression (IAS). Patients receive luteinizing hormone-releasing hormone (LHRH) analog (buserelin [BSRL], goserelin [ZDX], or leuprolide [LEUP]) and an antiandrogen (nilutamide [ANAN], flutamide [FLUT], bicalutamide [CDX], or cyproterone acetate [CPTR]) for 8 months. Patients receive LHRH analog by subcutaneous (SC) or intramuscular (IM) implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily, depending on the actual LHRH analog and antiandrogen. PSA levels are monitored every 2 months. If PSA falls to normal during the 8-month treatment period, therapy stops until levels rise to 10 ng/mL, at which time IAS resumes for another 8-month period. IAS continues as long as PSA levels are controlled. At the time of disease progression, patients begin continuous hormonal treatment similar to arm II.
- Arm II: Patients undergo continuous androgen deprivation without scheduled interruptions. Patients receive LHRH analog (BSRL, ZDX, or LEUP) with an antiandrogen (ANAN, FLUT, CDX, or CPTR) OR undergo bilateral orchiectomy within 5 days of randomization and receive an antiandrogen. Patients receive LHRH analog by SC or IM implant every 1-4 months beginning within 5 days of randomization and oral antiandrogen 1-3 times daily, depending on the actual LHRH analog and antiandrogen. PSA levels are monitored every 2 months. Treatment continues until hormone resistance develops. Patients receiving LHRH analog may begin antiandrogen therapy either prior to or simultaneously with LHRH analog and must continue antiandrogen therapy for at least 4 weeks to block tumor flare.
Quality of life is assessed at randomization, every 4 months for 2 years, every 8 months until development of hormone resistance, at the time of hormone resistance, and then annually thereafter.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 1,340 patients will be accrued for this study within 7 years.
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven adenocarcinoma of the prostate prior to the initiation of radiotherapy
- Prior pelvic radiotherapy for prostate cancer, either post-radical prostatectomy or as primary management
- More than 30 months since prior brachytherapy with curative intent
- Prostate-specific antigen must be rising and greater than 3 ng/mL and higher than the lowest level recorded previously since the end of radiotherapy (i.e., higher than the post-radiotherapy nadir)
- Total testosterone greater than 5 nmol/L
- No definite evidence of metastatic disease
- Chest x-ray and bone scan negative for metastases
- Radiological changes compatible with nonmalignant diseases allowed
- Clinical evidence of local disease allowed
PATIENT CHARACTERISTICS: Age:
- 16 and over (18 and over for participating centers in the United Kingdom)
Performance status:
- ECOG 0-1
Life expectancy:
- More than 5 years
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
- LDH no greater than 1.5 times ULN
- No chronic liver disease
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Sufficiently fluent and willing to complete the quality of life questionnaire in either English or French
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or superficial bladder cancer
PRIOR CONCURRENT THERAPY: Biologic therapy:
- No prior or concurrent biologic therapy
Chemotherapy:
- No prior or concurrent chemotherapy
Endocrine therapy:
- Prior hormonal therapy administered prior to, during, or immediately after radical radiotherapy or prostatectomy allowed provided duration was no longer than 12 months
- At least 12 months since prior hormonal therapy
Radiotherapy:
- See Disease Characteristics
- At least 12 months since prior radiotherapy
- No concurrent palliative radiotherapy
Surgery:
- See Disease Characteristics
- See Endocrine therapy
Other:
- No concurrent bisphosphonates
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Thomas P. Miller, MD 520-626-2667
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Thomas Dale Kummet, MD 602-277-5551
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Harinder S. Garewal, MD 520-629-4686
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Laura Fulper Hutchins, MD 501-686-8511 LFHutchins@uams.edu
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
Bart Barlogie, MD 501-526-2873
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
Joseph Szumowski, MD 510-465-8570
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Ian C. Anderson, MD 707-521-3830
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
John L. Barstis, MD 310-825-5268
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
David R. Gandara, MD 916-734-3772 dgandara@cc.ucdmc.ucdavis.edu
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Heinz-Josef Lenz, MD 323-865-3955 lenz@usc.edu
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
David R. Gandara, MD 925-372-2064
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Madeleine A. Kane, MD, PhD 303-399-8020 ext. 3129 madeleine.kane@med.va.gov
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Raoul R. Salup, MD 813-972-7579 raoul.salup@med.va.gov
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Thomas E. Seay, MD, PhD 404-851-2340
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
Patrick J. Stiff, MD 708-327-3148
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-569-6129
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Nirmala Bhoopalam, MD 708-202-2782
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7390, United States; Recruiting
James Brantley Thrasher, MD 913-588-6152 bthrasher@kumc.edu
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Michael A. Doukas, MD 859-257-3379
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Michael A. Doukas, MD 859-281-4956
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
Glenn M. Mills, MD 318-675-5970 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
German S. Beltran, MD 504-588-5482
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Glenn M. Mills, MD 318-221-8411
Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Douglas V. Faller, MD, PhD 617-638-4173
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekman@trinity-health.org
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Robert Anthony Chapman, MD 313-916-1332 rchapma1@hfhs.org
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0946, United States; Recruiting
Cheryl T. Lee, MD 734-615-6662
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
James Tate Thigpen, MD 601-362-4471
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Bethany G. Sleckman, MD 314-569-6573
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Paul J. Petruska, MD 314-268-5451 petruspj@slu.edu
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Patrick W. Cobb, MD 406-259-2245
New Jersey
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018-1095, United States; Recruiting
Patricia E. Gilhooly, MD 973-676-1000 ext. 3966 patricia.gilhooly@med.va.gov
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cheryl L. Willman, MD 505-272-5837
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
Cheryl L. Willman, MD 505-265-1711
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Daniel P. Petrylak, MD 212-305-1731 dpp5@columbia.edu
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Richard I. Fisher, MD 585-275-0842 richard_fisher@urmc.rochester.edu
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Amy D. Tiersten, MD 212-652-1916
Western New York Urology Associates, Buffalo, New York, 14220, United States; Recruiting
Scott David Perrapato, DO, FACOS 716-677-2273 sperrapato@wnyurologysouth.com
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Howard M. Gross, MD 937-832-1093
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH 513-584-3830
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
George Thomas Budd, MD 216-444-6480
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Albert F. Muhleman, MD 513-475-6537 albert.muhleman@med.va.gov
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Howard M. Gross, MD 937-268-6511
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Daniel J. Culkin, MD, FACS 405-271-6900 daniel-culkin@ouhsc.edu
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
Craig R. Nichols, MD 503-494-6346
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Christopher W. Ryan, MD 503-220-8262
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
Jeffrey Kent Giguere, MD 864-241-6251
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
James Dewitt Bearden, MD 864-560-7050
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Carolyn E. Reed, MD 843-792-9321 reedce@musc.edu
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Carolyn E. Reed, MD 843-789-7804
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Mohammad Jahanzeb, MD 901-722-0532
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Seth P. Lerner, MD 713-798-6841
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
Mitchell A. Garrison, MD 210-916-3281 mitchell.garrison@cen.amedd.army.mil
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
James E. Clarkson, MD 806-359-4673 ext. 228 jclarkson@harringtoncc.org
Southwest Cancer and Research Center at University Medical Center, Lubbock, Texas, 79415-3364, United States; Recruiting
Werner T. W. DeRiese, MD, PhD 806-775-8590 werner.deriese@ttumc.ttuhsc.edu
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, 79106, United States; Recruiting
Werner T. W. DeRiese, MD, PhD 806-775-8590
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
Geoffrey R. Weiss, MD 210-567-4777 weiss@uthscsa.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Robert P. Whitehead, MD 409-772-1164 rpwhiteh@utmb.edu
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Stephen E. Wright, MD 806-359-4673 ext. 230
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Geoffrey R. Weiss, MD 210-617-5186
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Phalguni Mukhopadhyay, MD 254-778-4811 ext. 4809
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Wolfram Samlowski, MD 801-585-0255 wolfram.samlowski@hci.utah.edu
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Wolfram Samlowski, MD 801-582-1565 ext. 1272
Virginia
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, 23510-1115, United States; Recruiting
Paul F. Schellhammer, MD 757-457-5182
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
Lauren Kenneth Colman, MD 253-403-5259 lauren.colman@multicare.org
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Andrew David Jacobs, MD 206-341-0446
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Saul E. Rivkin, MD 206-386-2441
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
William H. Schubach, MD 206-764-2265
Canada, Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada; Recruiting
Peter M. Venner, MD 780-432-8756 peterven@cancerboard.ab.ca
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, T2V-4R6, Canada; Recruiting
Bryan J. Donnelly, MD, FRCSC, MSC 403-259-2676
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, V1Y 5L3, Canada; Recruiting
Melanie Reed, MD, FRCPC 280-712-3900, ext. 3958
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada; Recruiting
Thomas A. Pickles, MD 604-877-6000 Ext. 2376
Fraser Valley Cancer Centre at Surrey Memorial Hospital, Surrey, British Columbia, V3V 1Z2, Canada; Recruiting
Winkle Kwan, MD 604-930-4085
G. Steinhoff Clinical Research, Victoria, British Columbia, V8V 3N1, Canada; Recruiting
Gary Steinhoff, MD 250-388-0840 gary@gsteinhoff.com
Prostate Centre at Vancouver General Hospital, Vancouver, British Columbia, V5Z 3J5, Canada; Recruiting
Sheldon Larry Goldenberg, MD, FRCSC, FACS 604-875-5003
Sunnybrook and Women's College Health Sciences Centre, Vancouver, British Columbia, V5Z 3J5, Canada; Recruiting
Sheldon Larry Goldenberg, MD, FRCSC, FACS 604-875-5003 lgold@interchange.ubc.ca
Canada, Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada; Recruiting
Ahmet Sakir Leylek, MD 204-787-2117 ahmet.leylek@cancercare.mb.ca
Canada, New Brunswick
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, E1C 8X3, Canada; Recruiting
Fernando Rojas, MD 506-862-4030
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada; Recruiting
Pradip K. Ganguly, MD 709-777-7805 pganguly@nctrf.nf.ca
Canada, Nova Scotia
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, B3H 1V7, Canada; Recruiting
Derek R. Wilke, MD, FRCPC 902-473-6022 Derek.Wilke@cdha.nshealth.ca
Canada, Ontario
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, N8W 2X3, Canada; Recruiting
Colvin D. Springer, MD 519-253-3191 Ext. 58513 colvin.springer@wrcc.on.ca
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, N6A 4L6, Canada; Recruiting
Glenn Stuart Bauman, MD 519-685-8650
Cancer Centre of Southeastern Ontario, Kingston, Ontario, K7L 5P9, Canada; Recruiting
Michael D. Brundage, MD 613-544-2630 Ext. 4506 michael.brondage@krcc.on.ca
Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital, Mississauga, Ontario, L5M 2N1, Canada; Recruiting
T.W. Short, MD 905-820-2263
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, L2R 5K3, Canada; Recruiting
Brian Peter Findlay, MD 905-682-6451
London Health Sciences Centre, London, Ontario, N6A 4G5, Canada; Recruiting
Joseph Chin, MD 519-685-8451 JCHIN@lhsc.on.ca
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, L8V 5C2, Canada; Recruiting
Thomas B. Corbett, MD, FRCPC 905-387-9495 Tom.Corbett@hrcc.on.ca
Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, P3E 5J1, Canada; Recruiting
Julie L. Bowen, MD 705-522-6237 Ext. 2144 jbowen@hrsrh.on.ca
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa, Ontario, K1H 1C4, Canada; Recruiting
Libni J. Eapen, MD, FRCPC 613-737-7700 Ext. 56771
Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada; Recruiting
Juanita M. Crook, MD 416-946-2919 juanita.crook@rmp.uhn.on.ca
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, P7B 6V4, Canada; Recruiting
Sunil Premlal P. Gulavita, MD 807-684-7200 sunilgulavita@cancercare.on.ca
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, M4N 3M5, Canada; Recruiting
Laurence H. Klotz, MD 416-480-4673
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, H2L-4M1, Canada; Recruiting
Fred Saad, MD, FRCS 514-890-8000 ext 27466 fredsaad@videotron.ca
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, G1R 2J6, Canada; Recruiting
Jacques Laverdiere, MD 418-691-5264
CHUS-Hopital Fleurimont, Sherbrooke, Quebec, J1H 5N4, Canada; Recruiting
Abdenour Nabid, MD 819-346-1110 ext. 14602 abdenour.nabid@usherbrooke.ca
Maisonneuve-Rosemont Hospital, Montreal, Quebec, H1T 2M4, Canada; Recruiting
Joycelyne Tessier, MD 514-252-3822
McGill Cancer Centre, Montreal, Quebec, H2W 1S6, Canada; Recruiting
Khalil Sultanem, MD 514-340-8288
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, S4T 7T1, Canada; Recruiting
Haji Ibrahim Chalchal, MD 306-766-2691 hchalchal@scf.sk.ca
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4, Canada; Recruiting
Iain M. MacLennan, MD 306-655-2709 iain.maclennan@scf.sk.ca
United Kingdom, England
Saint John Regional Hospital, Preston, England, PR2 9HT, United Kingdom; Recruiting
S. Kumar, MD 506-648-6884
Study chairs or principal investigators
Laurence H. Klotz, MD, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Celestia S. Higano, MD, Study Chair, University Cancer Center at University of Washington Medical Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000066745; CAN-NCIC-PR7; SWOG-JPR7; CAN-NCIC-JPR7; NCT00003653
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003653
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003653
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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