Not Signed In -
Lung Cancer |
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Clinical Trial: Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Squamous Cell Lung Cancer large cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer Adenocarcinoma of the Lung Bronchoalveolar Cell Lung Cancer | Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: gefitinib Procedure: chemotherapy Procedure: enzyme inhibitor therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: radiation therapy | Phase III |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Cisplatin, Etoposide, Radiotherapy, and Docetaxel With or Without Gefitinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Further Study Details:
OBJECTIVES:
- Compare cisplatin, etoposide, radiotherapy, and docetaxel with or without gefitinib, in terms of improving overall survival and progression-free survival, in patients with unresectable stage III non-small cell lung cancer.
- Determine the toxicity profile of gefitinib in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).
Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.
Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.
Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy.
- Arm I: Patients receive oral gefitinib daily.
- Arm II: Patients receive oral placebo daily. In both arms, maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 5 years and then annually for 5 years.
PROJECTED ACCRUAL: A total of 840 patients will be accrued for this study within 3.5 years.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed newly diagnosed single, primary bronchogenic non-small cell lung cancer (NSCLC)
- Adenocarcinoma
- Non-lobar and non-diffuse bronchoalveolar cell carcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unresectable stage IIIA disease
- Histologically or cytologically confirmed N2 status
- Multiple and/or bulky mediastinal lymph nodes on CT scan or x-ray
- Ineligible for induction chemotherapy or chemoradiotherapy followed by surgical resection
- Ineligible for or refused participation in SWOG-9336 OR
- Stage IIIB disease
- Pathologically or radiographically documented positive N3 nodes
- No positive supraclavicular or scalene lymph nodes with disease extending up into the cervical region OR
- Any documented T4 lesions invading the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina
- Mediastinal involvement without organ involvement allowed if soft tissue mass extends directly into the mediastinum
- Radiographic criteria for involvement of main pulmonary artery allowed if mediastinal soft tissue mass is present
- Single primary parenchymal lesion
- No other lesions on same or opposite sides of the lung
- No metastatic disease involving the contralateral chest, liver, or adrenals by CT scan of upper abdomen
- No malignant pleural or pericardial effusions
- Pleural effusions visible only on CT scan or too small to tap allowed
- Measurable or evaluable disease by CT scan, MRI, x-ray, or physical exam
- No brain metastases
PATIENT CHARACTERISTICS: Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Creatinine clearance at least 50 mL/min
Pulmonary:
- FEV
- at least 2.0 L OR
- FEV_1 less than 2.0 L if predicted FEV_1 of the contralateral lung is greater than 800 mL by quantitative split function testing
Other:
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No other concurrent non-cancer-related illness that would preclude study therapy
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy:
- No concurrent colony-stimulating factors during induction therapy
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy for NSCLC
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for NSCLC
Surgery:
- No prior surgical resection of NSCLC
- Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar diagnostic or staging surgery allowed
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 - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
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
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 Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Mark E. Reeves, MD, PhD 909-583-6064
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
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Edith A. Perez, MD 904-953-7283 perez.edith@mayo.edu
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 - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Swedish-American Regional Cancer Center, Rockford, Illinois, 61104-2315, United States; Recruiting
Lori Kline, RN, BS 815-489-4413 lkline@swedishamerican.org
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
Iowa
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
Siouxland Hematology-Oncology, Sioux City, Iowa, 51101-1733, United States; Recruiting
Donald Bruce Wender, MD, PhD 712-252-0088 shoaresearch@shoa-research.org
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, 66160-7353, United States; Recruiting
Sarah A. Taylor, MD 913-588-6029 sataylor@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
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910
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 beekmanl@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, 48109-0948, United States; Recruiting
Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Daniel Nikcevich, MD, PhD 218-786-3625 dnikcevich@smdc.org
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Coborn Cancer Center, Saint Cloud, Minnesota, 56303, United States; Recruiting
Harold E. Windschitl, MD 320-229-5199 windschitlh@centracare.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
James R. Jett, MD 507-284-2511
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, 55805, United States; Recruiting
James Edward Krook, MD 218-786-8364 jkrook@smdc.org
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
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
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
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
North Dakota
Altru Cancer Center, Grand Forks, North Dakota, 58201, United States; Recruiting
Todor Dentchev, MD 701-780-6363 tdentchev@altru.org
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Preston D. Steen, MD 701-234-6298 prestonsteen@meritcare.com
Medcenter One Health System, Bismarck, North Dakota, 58501-5505, United States; Recruiting
Edward J. Wos, DO 701-323-5741 ejwos@mohs.org
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
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
Mark Olsen, MD, PhD 918-499-2000 markolsen@usoncology.com
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
Pennsylvania
Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212-4772, United States; Recruiting
Jane Raymond, MD 412-359-8366
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, MD 570-271-6466
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
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org
Rapid City Regional Hospital, Rapid City, South Dakota, 57709, United States; Recruiting
Larry P. Ebbert, MD 605-341-8704
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Mohammad Jahanzeb, MD 901-722-0532
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Harvey B. Niell, MD 901-523-8990 ext. 5533
Texas
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
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Scott Michael Lippman, MD, FACP 713-745-3672
Medical City Dallas Hospital, Dallas, Texas, 75230, United States; Recruiting
Barry C. Mirtsching, MD 972-566-5588 bmirtsching@cortpa.com
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
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
Centre Hospitalier Regional de Rimouski, Quebec, G1S 4L8, Canada; Recruiting
Catherine Doyle, MD, FRCPC 418-682-7511
Canada, Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada; Recruiting
Christopher J. de Gara, MBBS, MS, FRCS Ed, Eng and C 780-432-8337 chrisdeg@cancerboard.ab.ca
Lethbridge Cancer Clinic, Lethbridge, Alberta, T1J 1W5, Canada; Recruiting
David Ross Holland, MD 403-329-0633
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, V1Y 5L3, Canada; Recruiting
David Fenton, MD 250-712-3900 ext. 3930 dfenton@bcancer.bc.ca
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, V8R 6V5, Canada; Recruiting
Brian H. Weinerman, MD 250-519-5501 bweinerm@becancer.bc.ca
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada; Recruiting
Nevin Murray, MD 604-877-6000 ext. 2730 nmurray@bccancer.bc.ca
G. Steinhoff Clinical Research, Victoria, British Columbia, V8V 3N1, Canada; Recruiting
Gary Steinhoff, MD 250-389-1177 gary@gsteinhoff.com
Lions Gate Hospital, North Vancouver, British Columbia, V7L 2P9, Canada; Recruiting
Paul Klimo, MD 604-984-5753
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital, Nanaimo, British Columbia, V9S 2B7, Canada; Recruiting
Christopher K.O. Williams, MD, FRCPC 250-755-7691 ext. 2784 cwilliam@nisa.net
Prostate Centre at Vancouver General Hospital, Vancouver, British Columbia, V5Z 3J5, Canada; Recruiting
Sheldon Larry Goldenberg, MD, FRCSC, FACS 604-875-5603
Providence Health Care - Vancouver, Vancouver, British Columbia, V6Z 1Y6, Canada; Recruiting
Linda Vickars, MD 604-684-5794 lvickars@providencehematology.com
Canada, Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada; Recruiting
Sri Navaratnam 204-787-2128
Canada, New Brunswick
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, E1C 8X3, Canada; Recruiting
Catherine Prady, MD 506-862-4022
Moncton Hospital, Moncton, New Brunswick, E1C 6ZB, Canada; Recruiting
Sheldon H. Rubin, MD 506-857-2881 shrubin@sehcc.health.nb.ca
Saint John Regional Hospital, Saint John, New Brunswick, E2L 4L2, Canada; Recruiting
Margot J. Burnell, MD 506-648-6884
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada; Recruiting
Kara Laing, MD 709-777-7802 klaing@nctrf.nf.ca
Canada, Nova Scotia
Cape Breton Cancer Centre, Sydney, Nova Scotia, B1P 1P3, Canada; Recruiting
Ron MacCormick, MD 902-567-8080 maccormickr@cbdha.nshealth.ca
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, B3H 1V7, Canada; Recruiting
Paul K. Joseph, MB, MS, FRCPC 902-473-6012 CCPKJ@qe2-hsc.ns.ca
Canada, Ontario
Algoma Regional Cancer Program at Sault Area Hospital, Sault Sainte Marie, Ontario, P6A 2C4, Canada; Recruiting
Paul L. D. Walde, MD 705-759-3434 ext. 4450 davidwalde@shaw.ca
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, N8W 2X3, Canada; Recruiting
Yasmin Alam 519-253-3191 ext. 58504
Cancer Centre of Southeastern Ontario, Kingston, Ontario, K7L 5P9, Canada; Recruiting
Wycliffe S. Lofters, MB, BS 613-544-2630 ext. 4505 wycliffe.lofters@krcc.on.ca
Durham Regional Cancer Centre at Lakeridge Health Oshawa, Oshawa, Ontario, L1G 2B9, Canada; Recruiting
Jose Chang, MD, FRCPC 905-576-8711 ext. 4298
Grand River Regional Cancer Centre at Grand River Hospital, Kitchner, Ontario, N2G 1G3, Canada; Recruiting
Gregory J. Knight, MD, FRCPC 519-749-4300 ext. 5715
Hamilton and District Urology Research Group, Hamilton, Ontario, L8N 1T8, Canada; Recruiting
J. Paul Whelan, MD 905-528-1266
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, L2R 5K3, Canada; Recruiting
Brian Peter Findlay, MD 905-682-6451
Humber River Regional Hospital - Weston, Weston, Ontario, M9N 1N8, Canada; Recruiting
Jonathan Jay Wilson, MD 416-243-4308 jwilson@hrrh.on.ca
London Health Sciences Centre, London, Ontario, N6A 4G5, Canada; Recruiting
Joseph Chin, MD 519-685-8451 JCHIN@lhsc.on.ca
Male Health Centre - North York, Toronto, Ontario, M6A 3B5, Canada; Recruiting
Jack Barkin, MD 416-256-9606 j.barkin@rogers.com
Male Health Centre - Oakville, Oakville, Ontario, L6H 3PI, Canada; Recruiting
Richard Casey, MD 905-338-3130 drcasey@malehealth.com
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, L8V 5C2, Canada; Recruiting
Andrew M. Arnold, MD 905-387-9495 andrew.arnold@hrcc.on.ca
Markham Stouffville Hospital, Markham, Ontario, L6B IAI, Canada; Recruiting
Henry L. Solow, MD 905-472-7000 mimic@on.aibn.com
Mount Sinai Hospital - Toronto, Toronto, Ontario, M5G 1X5, Canada; Recruiting
Ronald L. Burkes, MD, FRCPC 416-586-5117
North York General Hospital, Ontario, North York, Ontario, M2K 1E1, Canada; Recruiting
Mark Rother, MD 416-756-6704
Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, P3E 5J1, Canada; Recruiting
Jonathan Noble, MD, PhD 705-522-6237 ext. 2320
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa, Ontario, K1H 8L6, Canada; Recruiting
Scott A. Laurie, MD 613-737-7700 ext. 56809
Peterborough Oncology Clinic, Peterborough, Ontario, K9H 7B6, Canada; Recruiting
Rafal F. Wierzbicki, MD, FRCPC 705-743-2121 ext. 2361
Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada; Recruiting
Andrea Bezjak, MD, MSC, FRCPC 416-946-2132 andrea.bezjak@rmp.uhn.ca
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, P7B 6V4, Canada; Recruiting
Dimitrios Vergidis, MD 807-684-7200 vergidid@tbh.net
Royal Victoria Hospital of Barrie, Barrie, Ontario, L4M 6M2, Canada; Recruiting
Bryn Pressnail, MD 705-728-9802 pressnailb@rvh.on.ca
Scarborough Hospital - General Site, Scarborough, Ontario, M1P 2V5, Canada; Recruiting
Henry Krieger, MD 416-438-2911
Southlake Regional Health Centre, Newmarket, Ontario, L3Y 2P9, Canada; Recruiting
Labib A. Zibdawi, MD 905-895-4521, ext. 2297
St. Joseph's Health Centre - Toronto, Toronto, Ontario, M6R 1B5, Canada; Recruiting
Murray Davidson, MD 416-530-6000
St. Michael's Hospital - Toronto, Toronto, Ontario, M5B 1W8, Canada; Recruiting
Rashida Haq, MD, FRCPC 416-864-5912 hagr@smh.toronto.on.ca
Sunnybrook and Women's College Health Sciences Centre, North York, Ontario, M4N 3M5, Canada; Recruiting
Maureen E. Trudeau, MD, FRCPC 416-480-5145 maureeen.trudeau@sw.ca
Toronto East General Hospital, Toronto, Ontario, M4C 3E7, Canada; Recruiting
Yasmin Rahim, MD, FRCPC 416-469-3325 yrahi@tegh.on.ca
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, M4N 3M5, Canada; Recruiting
Yee C. Ung, MD, FRCPC 416-480-4951 yee.ung@sw.ca
Trillium Health Centre - Mississauga, Mississauga, Ontario, L5B 1B8, Canada; Recruiting
John A.P. Gapski, MD 905-270-3842
William Osler Health Centre, Brampton, Ontario, L6W 2Z8, Canada; Recruiting
Stephen M. Reingold, MD 905-451-6661 mox.reist@magic.pmh
Canada, Prince Edward Island
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, C1A 8T5, Canada; Recruiting
Dagny Elizabeth Dryer, MD 902-894-2027
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, (P.Q.) H2X 3J4, Canada; Recruiting
Anne-Marie Nutini, MD 514-890-8000 amnutini@moxeurrier.com
Centre Hospitalier Regional de Lanaudiere, Joliette, Quebec, J6E 6J2, Canada; Recruiting
Sarkis Santikyan, MD, FACP 450-759-8222
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, G1R 2J6, Canada; Recruiting
Michel Roy, MD 418-691-5392 michel.roy@ogy.ulaval.ca
CHUS-Hopital Fleurimont, Sherbrooke, Quebec, J1H 5N4, Canada; Recruiting
Jean Dufresne, MD 819-346-1110 jean.dufresne@usherbrooke.ca
Complexe Hospitalier de la Sagamie, Chicoutimi, Quebec, G7H 5H6, Canada; Recruiting
Raynald Simard, MD 418-541-1000
Hopital Charles Lemoyne, Greenfield Park, Quebec, J4V 2H1, Canada; Recruiting
Pierre Desjardins, MD 450-466-5065
Hopital Du Sacre-Coeur de Montreal, Montreal, Quebec, H4J 1C5, Canada; Recruiting
Bernard Lesperance, MD 514-338-2153 oncohsc@videotron.net
Hopital du Saint-Sacrement, Quebec, Quebec City, Quebec, G1S 4L8, Canada; Recruiting
Jean Robert, MD, FRCSC 418-682-7511
Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada; Recruiting
Albert Moghrabi, MD 514-345-4969 albert.moghrabi@umontreal.ca
Hotel Dieu de Montreal, Montreal, Quebec, H2W 1T8, Canada; Recruiting
Jacques Cantin, MD 514-890-8000 ext. 14950
Hotel-Dieu de Levis, Levis, Quebec, G6V 3Z1, Canada; Recruiting
Felix Couture, MD 418-691-5225 FelixCou@videotron.ca
L'Hopital Laval, Ste Foy, Quebec, G1V 4G5, Canada; Recruiting
Francis Laberge, MD 418-656-4747
Maisonneuve-Rosemont Hospital, Montreal, Quebec, H1T 2M4, Canada; Recruiting
Yves Eugene Leclerc, MD 514-252-3822
Canada, Saskatchewan
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4, Canada; Recruiting
David P. Skarsgard, MD 306-655-2740 david.skarsgard@saf.sk.ca
Study chairs or principal investigators
Karen Kelly, MD, Study Chair, University of Colorado Cancer Center
James R. Jett, MD, Study Chair, Mayo Clinic Cancer Center
Yee C. Ung, MD, FRCPC, Study Chair, Toronto Sunnybrook Regional Cancer Centre
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000068706; SWOG-S0023; CAN-NCIC-BR.15; NCCTG-S0023; CTSU; NCT00020709
Record last reviewed: March 2005
Last Updated: April 4, 2005
Record first received: July 11, 2001
ClinicalTrials.gov Identifier: NCT00020709
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: April 4, 2005
Record first received: July 11, 2001
ClinicalTrials.gov Identifier: NCT00020709
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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