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Clinical Trials (PDQ®)

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherRTOG 0815
CDR0000648194, NCI-2011-01948, NCT00936390

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

Further Study Information

OBJECTIVES:

Primary

  • Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT).

Secondary

  • Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients.
  • Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost).
  • Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment.

OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments). Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at discretion of treating physician and may include either 3D-conformal RT or intensity-modulated RT.
  • Arm II: Patients receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin) subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks after the first LHRH injection, patients undergo radiotherapy as in arm I.

After completion of study therapy, patients are followed up periodically.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 180 days and at intermediate-risk for recurrence by meeting ≥ 1 of the following criteria:
  • Gleason score > 7
  • Prostate Specific Antigen (PSA) > 10 and ≤ 20 ng/mL
  • Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech)
  • Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride)
  • Clinical stage T2b or T2c disease
  • Patients previously diagnosed with low-risk (Gleason score < 6, clinical stage < T2a, and PSA < 10 ng/mL) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate-risk disease according to the protocol criteria are eligible for enrollment within 6 months of the repeat biopsy procedure
  • Patients with Gleason Score ≥ 8, PSA > 20 ng/mL, OR clinical stage ≥ T3 are ineligible for this trial
  • If findings of extracapsular extension or seminal vesicle invasion are noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol
  • Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement
  • No patients with all 3 intermediate-risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer
  • The percentage of biopsy cores involved will only be considered with respect to eligibility for those patients with all 3 of the above risk factors (i.e., patients with one or two of the above risk factors are eligible irrespective of the percentage of biopsy cores involved)
  • Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors)
  • Abdominal imaging not required for a single intermediate-risk factor (these studies may be obtained at the discretion of the treating physician)
  • Lymph nodes that are equivocal or questionable by imaging allowed without biopsy if nodes ≤ 1.5 cm
  • Any node > 1.5 cm on imaging requires a negative biopsy
  • No evidence of bone metastases on bone scan within the past 60 days
  • Bone scan not required for patients with a single intermediate-risk factor (scan may be obtained at the discretion of the treating physician)
  • Equivocal bone scan findings allowed if plain film x-rays negative for metastasis

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm^3*
  • Platelet count ≥ 100,000/mm^3*
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve level allowed)*
  • NOTE: *For patients undergoing brachytherapy only.
  • Fertile patients must use effective contraception during and for the 3 months after cessation of protocol treatment
  • No invasive malignancy or hematological malignancy (e.g., leukemia, lymphoma, myeloma) within the past 5 years except adequately treated non-melanomatous skin cancer
  • Prior diagnoses of carcinoma in situ allowed
  • No severe or active co-morbidity with any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy, within the past 30 days
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Laboratory tests for liver function and coagulation parameters not required for entry into this protocol
  • AIDS based upon current Centers for Disease Control (CDC) definition
  • HIV testing not required for entry into this protocol
  • HIV-seropositive patients who do not meet criteria for diagnosis of AIDS allowed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radical surgery (prostatectomy), high-intensity focused ultrasound, or cryosurgery for prostate cancer
  • No prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
  • No finasteride within past 30 days (90 days for dutasteride)
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer
  • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy (RT), including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
  • Patients undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score ≤ 15 within the past 60 days of registration, and no history of prior transurethral resection of the prostate (TURP)
  • TURP allowed for patients who receive external-beam radiation therapy only

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

NRG Oncology

Alvaro A. MartinezStudy Chair

Trial Sites

U.S.A.
Alaska
  Fairbanks
 Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
 Huong T. Pham Ph: 206-342-6954
  Email: vmmc.cancer_clinical_research@VirginiaMason.org
Arizona
  Peoria
 Arizona Center for Cancer Care - Peoria
 Daniel R Reed Ph: 623-773-2873
  Scottsdale
 21st Century Oncology - Scottsdale
 Karen A Finkelstein Ph: 505-843-7813
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 800-360-6371
 Mayo Clinic Scottsdale
 Richard (Chunhee) Choo Ph: 507-538-7623
  Tucson
 Arizona Oncology - Tucson
 Vivek S Kavadi Ph: 281-277-5200
Arkansas
  Hot Springs
 St. Joseph's Mercy Cancer Center
 David E. Pruitt Ph: 501-686-8274
California
  Auburn
 Auburn Radiation Oncology
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Matthew C Solhjem Ph: 503-215-6412
  Chico
 Enloe Cancer Center at Enloe Medical Center
 Grace E Yuh Ph: 530-332-3808
  El Segundo
 21st Century Oncology - El Segundo
 David Khan Ph: 888-326-9729
  Greenbrae
 Marin Cancer Institute at Marin General Hospital
 Lloyd T Miyawaki Ph: 415-925-7325
  Long Beach
 Veterans Affairs Medical Center - Long Beach
 Samar H. Azawi Ph: 562-826-8000
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Leslie Ballas Ph: 323-865-0451
 Leslie Ballas Ph: 323-865-0451
  Modesto
 Memorial Medical Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Oakland
 Kaiser Permanente-Oakland
 Louis Fehrenbacher Ph: 626-564-3455
  Palm Springs
 Desert Regional Medical Center Comprehensive Cancer Center
 Amir Lavaf Ph: 760-416-4730
  Paradise
 Feather River Hospital Cancer Center
 Sam Mazj Ph: 530-876-7995
  Email: haleew@ah.org
  Pomona
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Yallapragada S. Rao Ph: 909-865-9555
  Rancho Cardova
 Kaiser Permanente Medical Center - Rancho Cordova
 Louis Fehrenbacher Ph: 626-564-3455
  Rohnert Park
 Rohnert Park Cancer Center
 Louis Fehrenbacher Ph: 626-564-3455
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
 The Permanente Medical Group-Roseville Radiation Oncology
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 South Sacramento Cancer Center
 Louis Fehrenbacher Ph: 626-564-3455
 Sutter Cancer Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
 University of California Davis Cancer Center
 Richard K. Valicenti Ph: 916-734-3089
  Saint Helena
 Saint Helena Hospital
 David J Tate Ph: 707-967-3698
  San Diego
 Rebecca and John Moores UCSD Cancer Center
 Loren K Mell Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  San Francisco
 California Pacific Medical Center - California Campus
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
 UCSF Helen Diller Family Comprehensive Cancer Center
 I-Chow J Hsu Ph: 877-827-3222
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Cancer Treatment Center
 Louis Fehrenbacher Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Mark K Buyyounouski Ph: 650-498-7061
  Email: ccto-office@stanford.edu
  Vacaville
 Solano Radiation Oncology Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Vallejo
 Sutter Solano Medical Center
 Christopher Jones Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
Colorado
  Fort Collins
 Poudre Valley Hospital
 Joshua H Petit Ph: 970-482-3328
Connecticut
  Bridgeport
 St. Vincent's Medical Center
 Christopher M Iannuzzi Ph: 203-576-6329
  Email: twhite@stvincents.org
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Samir Narayan Ph: 734-712-4673
  Hew Haven
 Father Michael J. McGivney Center for Cancer Care at Hospital of Saint Raphael
 Joseph G. Cardinale Ph: 203-789-3545
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Adam Raben Ph: 302-733-6227
 Adam Raben Ph: 302-733-6227
District of Columbia
  Washington
 Washington Cancer Institute at Washington Hospital Center
 Pamela Randolph Ph: 202-877-8839
Florida
  Deerfield Beach
 University of Miami/Deerfield Beach
 Alan Pollack Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Fort Lauderdale
 Broward General Medical Center Cancer Center
 Evan M Landau Ph: 954-355-5346
  Jacksonville
 Mayo Clinic - Jacksonville
 Richard (Chunhee) Choo Ph: 507-538-7623
  Kissimmee
 Florida Hospital Kissimmee
 Robert J Sollaccio Ph: 407-303-5623
  Lakeland
 Center for Cancer Care and Research at Watson Clinic, LLP
 John T Barrett Ph: 863-680-7780
  Miami
 Jackson Memorial Hospital
 Alan Pollack Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
 South Miami Hospital
 Maria-Amelia M Rodrigues Ph: 888-823-5923
  Email: ctsucontact@westat.com
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Alan Pollack Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
  Tampa
 Veterans Affairs Medical Center - Tampa
 Babu Zachariah Ph: 800-456-7121
  Email: canceranswers@moffitt.org
Georgia
  Atlanta
 Georgia Cancer Center for Excellence at Grady Memorial Hospital
 Ashesh B. Jani Ph: 404-778-1868
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
 Winship Cancer Institute of Emory University
 Scott Edelman Ph: 404-321-6111ext7632
  Columbus
 John B. Amos Cancer Center
 Douglas F. Ciuba Ph: 706-660-6404
  Gainesville
 Northeast Georgia Medical Center
 Frank G. Lake Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Paul A. DeMare Ph: 808-545-8548
 Hawaii Medical Center - East
 Paul A. DeMare Ph: 808-545-8548
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-4673
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Chicago
 Creticos Cancer Center at Advocate Illinois Masonic Medical Center
 Santosh V Yajnik Ph: 773-296-5360
 John H. Stroger, Jr. Hospital of Cook County
 Anupama Thakrar Ph: 312-864-6000
 University of Chicago Cancer Research Center
 Stanley L Liauw Ph: 773-834-7424
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Hines
 Veterans Affairs Medical Center - Hines
 William Small Ph: 708-226-4357
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Matthew M Harkenrider Ph: 708-226-4357
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Springfield
 Cancer Institute at St. John's Hospital
 Cathy L. Clausen Ph: 217-525-5666
  Email: diana.weyhenmeyer@st-johns.org
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Anderson
 Saint John's Health System
 Alexander M. Yeh Ph: 765-646-8358
  Avon
 Clarian West Medical Center
 Mark P Langer Ph: 317-274-2552
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
 Radiation Oncology Associates Southwest
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Mark P Langer Ph: 317-274-2552
 Methodist Cancer Center at Methodist Hospital
 Mark P Langer Ph: 317-274-2552
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Dubuque
 Wendt Regional Cancer Center at Finley Hospital
 James R. Baer Ph: 877-275-7724
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Fen Wang Ph: 913-588-4709
Kentucky
  Lexington
 Central Baptist Hospital
 Alan Beckman Ph: 859-260-6425
 University of Kentucky Chandler Medical Center
 William H St. Clair Ph: 859-257-3379
  Owensboro
 Mitchell Memorial Cancer Center at Owensboro Medical Health System
 Samuel R Faught Ph: 270-688-3691
  Email: shawns@omhs.org
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Troy G. Scroggins Ph: 888-562-4763
 Tulane Cancer Center at Tulane University Hospital and Clinic
 William R. Robinson Ph: 504-988-6121
Maine
  Lewiston
 Central Maine Comprehensive Cancer Center at Central Maine Medical Center
 Courtney A Jensen Ph: 207-795-8250
  Email: benderli@cmhc.org
  Scarborough
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
  Email: wrighd@mmc.org
Maryland
  Annapolis
 DeCesaris Cancer Institute at Anne Arundel Medical Center
 Angel E. Torano Ph: 443-481-1320
  Email: kbodenhorn@aahs.org
  Baltimore
 St. Agnes Hospital Cancer Center
 Richard S. Hudes Ph: 410-368-2910
  Silver Spring
 Holy Cross Hospital
 Daniel H Clarke Ph: 310-754-7552
Massachusetts
  Boston
 Massachusetts General Hospital
 Jason A Efstathiou Ph: 877-726-5130
  Fall River
 Hudner Oncology Center at Saint Anne's Hospital - Fall River
 Michele Albert Ph: 508-674-5600ext2515
  Hyannis
 Davenport-Mugar Cancer Center at Cape Cod Hospital
 Daniel J Canaday Ph: 508-862-5799
  Lowell
 Lowell General Hospital
 Jason A Efstathiou Ph: 877-726-5130
  Peabody
 NSMC Cancer Center - Peabody
 Jason A Efstathiou Ph: 877-726-5130
  Pittsfield
 Berkshire Hematology Oncology, PC
 Harvey Zimbler Ph: 413-496-8205
  Email: ggero@bhs1.org
  Plymouth
 Jordan Hospital Club Cancer Center
 James M Koomey Ph: 508-830-2390
  Email: cancerinfo@jordanhospital.org
  Worcester
 Saint Vincent Hospital - Fallon Clinic
 William B Casey Ph: 508-363-7018
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-4673
 University of Michigan Comprehensive Cancer Center
 Daniel A Hamstra Ph: 800-865-1125
 Alvaro Martinez
  Email: alvaro.martinez@rtsx.com
 Veterans Affairs Medical Center - Ann Arbor
 Kyle C Cuneo Ph: 800-865-1125
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Clinton Township
 Henry Ford Macomb Hospital
 Eleanor M. Walker Ph: 313-916-1784
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Eleanor M. Walker Ph: 313-916-1784
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Samir Narayan Ph: 734-712-4673
  Farmington Hills
 21st Century Oncology-Farmington Hills
 Jeffrey D. Forman Ph: 248-858-6215
  Flint
 Genesys Hurley Cancer Institute
 Samir Narayan Ph: 734-712-4673
 McLaren Cancer Institute
 Hesham E. Gayar Ph: 810-342-4071
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Samir Narayan Ph: 734-712-4673
  Lapeer
 Great Lakes Cancer Institute - Lapeer Campus
 Hesham E. Gayar Ph: 810-342-4071
  Mount Clemens
 Clemens Regional Medical Center
 Hesham E. Gayar Ph: 810-342-4071
  Mount Pleasant
 Norval K. Morey Cancer Center at Central Michigan Community Hospital
 Hesham E. Gayar Ph: 810-342-4071
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Owosso
 Great Lakes Cancer Institute - Owosso
 Hesham E. Gayar Ph: 810-342-4071
  Petoskey
 Northern Michigan Hospital
 Hesham E. Gayar Ph: 810-342-4071
  Pontiac
 St. Joseph Mercy Oakland
 Samir Narayan Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Samir Narayan Ph: 734-712-4673
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Daniel J Krauss Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Samir Narayan Ph: 734-712-4673
  Troy
 William Beaumont Hospital - Troy Campus
 Daniel J Krauss Ph: 248-551-7695
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-4673
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Duluth
 Miller - Dwan Medical Center
 Daniel Nikcevich Ph: 888-203-7267
 St. Luke's Hospital Cancer Care Center
 Steven R Bonin Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Edina
 Fairview Southdale Hospital
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Richard (Chunhee) Choo Ph: 507-538-7623
  Saint Paul
 Regions Hospital Cancer Care Center
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Saint Louis
 Barnes-Jewish West County Hospital
 Jeff M. Michalski Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Jeff M. Michalski Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Saint Peters
 Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
 Jeff M. Michalski Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Omaha
 Fred and Pamela Buffett Cancer Center
 Andrew O Wahl Ph: 800-999-5465
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Lakeside Hospital
 Gamini S. Soori Ph: 402-280-4100
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
New Hampshire
  Concord
 Payson Center for Cancer Care at Concord Hospital
 Su K Metcalfe Ph: 800-441-1138
  Exeter
 Center for Cancer Care at Exeter Hospital
 Gary Miller Proulx Ph: 800-439-3837
  Keene
 Kingsbury Center for Cancer Care at Cheshire Medical Center
 Alan C. Hartford Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Alan C. Hartford Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
  Manchester
 Elliot Regional Cancer Center at Elliot Hospital
 Brian R Knab Ph: 603-663-1800
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Ashraf F Youssef Ph: 856-325-6757
  East Orange
 Veterans Affairs Medical Center - East Orange
 Anudh K Jain Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Lemuel S. Ariaratnam Ph: 888-847-8823
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Maria Werner-Wasik Ph: 215-955-6084
  Toms River
 J. Phillip Citta Regional Cancer Center at Community Medical Center
 David J D'Ambrosio Ph: 732-818-3882
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Ashraf F Youssef Ph: 856-325-6757
  West Orange
 Prostate Cancer Center of New Jersey
 Robert Ivker Ph: 888-823-5923
  Email: ctsucontact@westat.com
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Benny J. Liem Ph: 505-272-6972
 Alvaro Martinez
  Email: alvaro.martinez@rtsx.com
  Las Cruces
 Memorial Medical Center
 Benny J. Liem Ph: 505-272-6972
New York
  Bay Shore
 Southside Hospital
 Louis Potters Ph: 516-562-3467
  Buffalo
 Roswell Park Cancer Institute
 Michael R. Kuettel Ph: 877-275-7724
  Canandiaqua
 Sands Cancer Center
 Yuhchyau Chen Ph: 585-275-5830
  New Hyde Park
 Long Island Jewish Medical Center
 Louis Potters Ph: 516-562-3467
 Monter Cancer Center of the North Shore-LIJ Health System
 Louis Potters Ph: 516-562-3467
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Israel Deutsch Ph: 212-305-8615
  Poughkeepsie
 Hudson Valley Oncology Associates
 Maria Werner-Wasik Ph: 215-955-6084
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
 University Radiation Oncology at Parkridge Hospital
 Yuhchyau Chen Ph: 585-275-5830
North Carolina
  Durham
 Duke Cancer Institute
 W. Robert Lee Ph: 888-275-3853
  Morehead City
 Coleman Radiation Oncology Center at Carter General Hospital
 Michael A Papagikos Ph: 910-251-1839
  New Bern
 CarolinaEast Cancer Care
 Michael A Papagikos Ph: 910-251-1839
  Raleigh
 Rex Cancer Center at Rex Hospital
 Leroy G Hoffman Ph: 919-784-7209
  Supply
 South Atlantic Radiation Oncology, LLC
 Michael A Papagikos Ph: 910-251-1839
  Wilmington
 Coastal Carolina Radiation Oncology Center
 Michael A Papagikos Ph: 910-251-1839
North Dakota
  Bismarck
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
  Minot
 Trinity CancerCare Center
 Kevin Basil Collins Ph: 800-862-0005
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Lee Fromm Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Chardon
 Geauga Regional Hospital
 Rodney J Ellis Ph: 800-641-2422
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cincinnati
 University of Cincinnati
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Case Comprehensive Cancer Center
 Rodney J Ellis Ph: 800-641-2422
  Columbus
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Elyria
 Mercy Cancer Center - Elyria
 Rodney J Ellis Ph: 800-641-2422
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Medina
 Summa Health Center at Lake Medina
 Charles A Kunos Ph: 330-375-6101
  Mentor
 Lake/University Ireland Cancer Center
 Rodney J Ellis Ph: 800-641-2422
  Middleburg Heights
 Southwest General Health Center
 Rodney J Ellis Ph: 800-641-2422
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Rodney J Ellis Ph: 800-641-2422
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 Alvaro Martinez
  Email: alvaro.martinez@rtsx.com
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
  Sandusky
 University Hospitals Ireland Cancer Center at Firelands Regional Medical Center
 Rodney J Ellis Ph: 800-641-2422
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  West Chester
 University Pointe
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Westlake
 UHHS Westlake Medical Center
 Rodney J Ellis Ph: 800-641-2422
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Matthew C Solhjem Ph: 503-215-6412
  Eugene
 Willamette Valley Cancer Center - Eugene
 Vivek S Kavadi Ph: 281-277-5200
  Grants Pass
 Three Rivers Community Hospital
 Gordon L. Metz Ph: 541-789-6176
  Gresham
 Legacy Mount Hood Medical Center
 Andrew Y Kee Ph: 507-538-7623
  Medford
 Dubs Cancer Center at Rogue Valley Medical Center
 Gordon L. Metz Ph: 541-789-6176
 Providence Cancer Center at PMCC
 Gordon L. Metz Ph: 541-789-6176
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Andrew Y Kee Ph: 507-538-7623
 Providence Cancer Center at Providence Portland Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Matthew C Solhjem Ph: 503-215-6412
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Wayne H Pinover Ph: 215-481-2402
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
  Darby
 Mercy Fitzgerald Hospital
 Maria Werner-Wasik Ph: 215-955-6084
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Rachelle M. Lanciano Ph: 610-284-8237
  Email: jolene.garney@crozer.org
  Dunmore
 Northeast Radiation Oncology Center
 Maria Werner-Wasik Ph: 215-955-6084
  Erie
 Regional Cancer Center - Erie
 Andrew T Figura Ph: 814-838-0448
  Email: mhaynes@trcc.org
  Gettysburg
 Adams Cancer Center
 Amit B. Shah Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Amit B. Shah Ph: 877-441-7957
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Justin J Juliano Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Milford
 Upper Delaware Valley Cancer Center
 Maria Werner-Wasik Ph: 215-955-6084
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Eric Horwitz Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Maria Werner-Wasik Ph: 215-955-6084
 Radiation Therapy Oncology Group
 Alvaro Martinez Ph: 248-553-0606
  Email: Alvaro.Martinez@rtsx.com
  Pittsburgh
 Veterans Affairs Medical Center - Pittsburgh
 Kristina Gerszten Ph: 412-688-6104
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
  York
 WellSpan Health
 Amit B. Shah Ph: 877-441-7957
South Carolina
  Anderson
 AnMed Cancer Center
 Patricia C Griffin Ph: 800-486-5941
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 David T Marshall Ph: 843-792-9321
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 David T Marshall Ph: 843-792-9321
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
 Gibbs Cancer Center-Pelham
 Patricia C Griffin Ph: 800-486-5941
  Myrtle Beach
 Carolina Regional Cancer Center
 Patrick M Francke Ph: 877-460-2657
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
  Email: research@rcrh.org
Tennessee
  Knoxville
 Thompson Cancer Survival Center
 Daniel D Scaperoth Ph: 865-541-1812
Texas
  Austin
 Texas Oncology - Midtown Austin
 Vivek S Kavadi Ph: 281-277-5200
 Texas Oncology, PA at South Austin Cancer Center
 Vivek S Kavadi Ph: 281-277-5200
 Texas Oncology, PA at Texas Oncology Cancer Center - Central
 Vivek S Kavadi Ph: 281-277-5200
  Bedford
 Texas Oncology, PA at Harris Center HEB
 Vivek S Kavadi Ph: 281-277-5200
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David A. Pistenmaa Ph: 214-648-7097
  Denton
 Texas Oncology, PA at Texas Cancer Center - Denton South
 Vivek S Kavadi Ph: 281-277-5200
  Fort Worth
 Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
 Vivek S Kavadi Ph: 281-277-5200
  Houston
 Memorial Hermann Hospital - Memorial City
 Vivek S Kavadi Ph: 281-277-5200
 Univeristy of Texas M.D. Anderson Cancer Center
 Thomas J Pugh Ph: 713-792-3245
  Longview
 Longview Cancer Center
 Vivek S Kavadi Ph: 281-277-5200
  Round Rock
 Texas Oncology, PA - Seton Williamson
 Vivek S Kavadi Ph: 281-277-5200
 Texas Oncology, PA at Texas Cancer Center Round Rock
 Vivek S Kavadi Ph: 281-277-5200
  Sherman
 Texas Oncology, PA at Texas Cancer Center - Sherman
 Vivek S Kavadi Ph: 281-277-5200
  Sugar Land
 Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
 Vivek S Kavadi Ph: 281-277-5200
Utah
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee Ph: 801-507-3950
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 R. Jeffrey Lee Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 R. Jeffrey Lee Ph: 801-507-3950
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Jonathan D Tward Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
 LDS Hospital
 R. Jeffrey Lee Ph: 801-507-3950
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee Ph: 801-507-3950
Vermont
  Rutland
 Community Cancer Center at Rutland Regional Medical Center
 Richard D. Lovett Ph: 802-775-7111
  Saint Johnsbury
 Norris Cotton Cancer Center - North
 Alan C. Hartford Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
Virginia
  Alexandria
 INOVA Alexandria Hospital
 Jane Grayson Ph: 703-776-2580
  Email: research@inova.org
  Fishersville
 Augusta Medical Center Cancer Center
 Robert M Kyler Ph: 540-689-7000
  Hampton
 Sentara Cancer Institute at Sentara CarePlex Hospital
 Mark E Shaves Ph: 757-388-2406
  Norfolk
 Sentara Cancer Institute at Sentara Norfolk General Hospital
 Mark E Shaves Ph: 757-388-2406
  Portsmouth
 Naval Medical Center - Portsmouth
 Edward F Miles Ph: 757-953-5939
  Roanoke
 Blue Ridge Cancer Care - Roanoke
 Vivek S Kavadi Ph: 281-277-5200
  Virginia Beach
 Coastal Cancer Center at Sentara Virginia Beach General Hospital
 Mark E Shaves Ph: 757-388-2406
Washington
  Bellingham
 St. Joseph Cancer Center
 Michael Andre Taylor Ph: 360-788-8223
  Email: cpatz@peacehealth.org
  Federal Way
 St. Francis Hospital
 John A Keech Ph: 907-458-5380
  Seattle
 CCOP - Virginia Mason Research Center
 Huong T. Pham Ph: 206-342-6954
  Email: vmmc.cancer_clinical_research@VirginiaMason.org
  Vancouver
 Legacy Salmon Creek Medical Center
 Andrew Y Kee Ph: 507-538-7623
 Northwest Cancer Specialists at Vancouver Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
 Southwest Washington Medical Center Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
Wisconsin
  Green Bay
 Bellin Memorial Hospital
 Charlie C Pan Ph: 920-435-8326
 St. Mary's Hospital Medical Center - Green Bay
 James L Leenstra Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  La Crosse
 Franciscan Skemp Healthcare - La Crosse Campus
 David J Schwartz Ph: 608-392-9462
 Gundersen Lutheran Center for Cancer and Blood
 Collin D Driscoll Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 James L Leenstra Ph: 920-433-8889
 Vince Lombardi Cancer Clinic - Marinette
 Mitchell H. Pincus Ph: 800-252-2990
  Menomonee Falls
 Community Memorial Hospital Cancer Care Center
 Colleen A. Lawton Ph: 414-805-4380
  Mequon
 Columbia Saint Mary's Hospital - Ozaukee
 Craig A Schulz Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
  Milwaukee
 Columbia-Saint Mary's Cancer Care Center
 Craig A Schulz Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
 Froedtert Hospital and Medical College of Wisconsin
 Colleen A. Lawton Ph: 414-805-4380
 Veterans Affairs Medical Center - Milwaukee
 Elizabeth M. Gore Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  Racine
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James H. Taylor Ph: 414-874-4541
  Email: Kelli.holton@wfhc.org
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 James L Leenstra Ph: 920-433-8889
  Summit
 Aurora Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Mitchell H. Pincus Ph: 800-252-2990
  West Bend
 Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital
 Colleen A. Lawton Ph: 414-805-4380
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Steve J Angyalfi Ph: 403-521-3433
  Edmonton
 Cross Cancer Institute at University of Alberta
 Nawaid Usmani Ph: 780-432-8500
British Columbia
  Kelowna
 British Columbia Cancer Agency - Centre for the Southern Interior
 Ross M Halperin Ph: 250-712-3900
New Brunswick
  Saint John
 Saint John Regional Hospital
 Holly Campbell Ph: 506-648-6890
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Derek R Wilke Ph: 902-473-6000
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Ian S Dayes Ph: 905-387-9495
  Kitchener
 Grand River Regional Cancer Centre at Grand River Hospital
 Darindra D Gopaul Ph: 519-749-4300ext2307
  London
 London Regional Cancer Program at London Health Sciences Centre
 David P. D'Souza Ph: 519-685-8600
  Ottawa
 Ottawa Hospital Regional Cancer Centre - General Campus
 Gad A Perry Ph: 613-761-4395
  Email: info@ohri.ca
  Thunder Bay
 Cancer Care Program at Thunder Bay Regional Health Sciences
 Sunil Premial P Gulavita Ph: 877-696-7223
  Email: cancercareinfo@tbh.net
  Toronto
 Odette Cancer Centre at Sunnybrook
 Gerard Morton Ph: 416-480-5000
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Jean-Paul Bahary Ph: 514-890-8000ext23611
  Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca
 Maisonneuve-Rosemont Hospital
 Peter Vavassis Ph: 514-252-3400ext3329
 McGill Cancer Centre at McGill University
 Fabio L Cury Ph: 514-398-1444
  Email: penny.chipman@mcgill.ca
  Quebec City
 Centre Hospitalier Universitaire de Quebec
 Eric Vigneault Ph: 418-525-4444
  Sherbrooke
 CHUS-Hopital Fleurimont
 Abdenour Nabid Ph: 819-820-6480
  Email: crcinformation.chus@ssss.gouv.qc.ca
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 T.H. P Tai Ph: 306-766-2213
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Ali A El-Gayed Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00936390
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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