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

Basic Trial Information

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Further Study Information

OBJECTIVES:

Primary

• To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.

Secondary

• To monitor and compare progression-free survival for "safety".

• To compare patterns of failure (locoregional vs distant).

• To compare acute toxicity profiles (and overall toxicity burden).

• To compare overall quality of life (QOL) short-term (< 6 months) and long-term (2 years).

• To compare QOL Swallowing Domains short-term and long-term.

• To compare clinician-reported versus patient-reported CTCAE toxicity events.

• To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.

• To explore differences in work status and time to return to work.

• To compare patient-reported changes in hearing.

• To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.

• To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.

• To pilot CASI collection of patient reported outcomes in a cooperative group setting.

• To determine whether specific molecular profiles are associated with overall or progression-free survival.

• To investigate associations between changes in serum biomarkers or HPV-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.

OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs > 10 pack-years). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive high-dose cisplatin IV over 1-2 hours on days 1 and 22.

• Arm II: Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours. Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients undergo IMRT as in arm I.

Tumor tissue and blood samples are collected at baseline and may also be collected at 3- and 6-month follow-up visits for correlative studies.

Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.

After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)

• No cancer from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal, or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive

• No carcinoma of the neck of unknown primary site origin (even if p16 positive)

• Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx

• Clinical evidence should be documented; may consist of palpation, imaging, or endoscopic evaluation; and should be sufficient to estimate the size of the primary (for T stage)

• No distant metastasis or adenopathy below the clavicles

• Patients must be positive for p16, determined by the OSU Innovation Center CLIA lab prior to step 2 registration (randomization)

• Paraffin-embedded cytology specimens are acceptable for p16 evaluation, but cytology smears are not

• Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations

• Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site

• Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions

• Fine-needle aspirations of the neck are insufficient due to limited tissue for retrospective central review

• Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required

• Clinical stage T1-2 N2a-N3 or T3-4 any N, including no distant metastases

• No clinical stage T1-2 N0-1

• No simultaneous primaries or bilateral tumors

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)

• Bilirubin ≤ 2 mg/dL

• AST or ALT ≤ 3 times upper limit of normal

• Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min

• Negative pregnancy test

• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study, and until at least 60 days following the last study treatment

• Patients who are HIV-positive and have no prior AIDS-defining illness and have CD4 cells of at least 340/mm³ are eligible

• HIV status must be known prior to registration

• No multidrug resistance for HIV infection

• Not seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or hepatitis C (anti-hepatitis C antibody positive)

• Immunity to hepatitis B (anti-hepatitis B surface antibody positive) allowed

• No prior invasive malignancy except non-melanoma skin cancer, or malignancy for which the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix)

• No severe, active co-morbidity, defined as any of the following:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

• Transmural myocardial infarction within the last 6 months

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

• Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol

• Immunocompromised patients

• No prior allergic reaction to cisplatin or cetuximab

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic chemotherapy for the study cancer

• Prior chemotherapy for a different cancer allowed

• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

• No prior cetuximab or other anti-EGFR therapy

• No concurrent amifostine as a radioprotector

• No concurrent granulocyte colony-stimulating factor or erythropoietin

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

Andy M. Trotti

Principal Investigator

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		John B Halligan	Ph: 907-261-3109
California
	Auburn
	Auburn Radiation Oncology
		Christopher Jones	Ph: 916-646-8300
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Christopher Jones	Ph: 916-646-8300
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Christopher Jones	Ph: 916-646-8300
	Chico
	Enloe Cancer Center at Enloe Medical Center
		Grace E Yuh	Ph: 530-332-3808
	Duarte
	City of Hope Comprehensive Cancer Center
		Nayana L. Vora	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	LA Jolla
	Rebecca and John Moores UCSD Cancer Center
		Loren K Mell	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
	Los Angeles
	Kaiser Permanente Medical Center - Los Angeles
		Michael R Girvigian	Ph: 626-564-3455
	Modesto
	Memorial Medical Center
		Jorge A Garcia-Young	Ph: 209-572-7116
	Oakland
	Kaiser Permanente-Oakland
		Louis Fehrenbacher	Ph: 626-564-3455
	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: 916-646-8300
	The Permanente Medical Group-Roseville Radiation Oncology
		Louis Fehrenbacher	Ph: 626-564-3455
	Sacramento
	Mercy General Hospital
		Christopher Jones	Ph: 916-646-8300
	Radiological Associates of Sacramento Medical Group, Incorporated
		Christopher Jones	Ph: 916-646-8300
	South Sacramento Cancer Center
		Louis Fehrenbacher	Ph: 626-564-3455
	Saint Helena
	Saint Helena Hospital
		David J Tate	Ph: 707-967-3698
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Sue S Yom	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 Pasadena
	City of Hope Medical Group, Incorporated
		Nayana L. Vora	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	South San Francisco
	Kaiser Permanente Cancer Treatment Center
		Louis Fehrenbacher	Ph: 626-564-3455
	Stanford
	Stanford Cancer Center
		Quynh-Thu X Le	Ph: 650-498-7061
			Email: clinicaltrials@med.stanford.edu
	Vacaville
	Solano Radiation Oncology Center
		Christopher Jones	Ph: 916-646-8300
	Vallejo
	Sutter Solano Medical Center
		Ari D Baron	Ph: 510-204-3428
Colorado
	Aurora
	Rocky Mountain Cancer Centers - Aurora
		Eduardo R. Pajon	Ph: 888-785-6789
	University of Colorado Cancer Center at UC Health Sciences Center
		David Raben	Ph: 720-848-0650
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Alan T Monroe	Ph: 888-785-6789
	Denver
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Thornton
	Rocky Mountain Cancer Centers - Thornton
		Eduardo R. Pajon	Ph: 888-785-6789
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Samir Narayan	Ph: 734-712-3456
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Neal B Goldberg	Ph: 860-224-5660
Delaware
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Adam Raben	Ph: 302-733-6227
Florida
	Deerfield Beach
	North Broward Medical Center
		Marshal E Lieberfarb	Ph: 954-941-8300
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Marshal E Lieberfarb	Ph: 954-941-8300
	Hollywood
	Joe DiMaggio Children's Hospital
		Ignacio Castellon	Ph: 888-823-5923
			Email: ctsucontact@westat.com
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Michael R Olson	Ph: 904-202-7051
	Integrated Community Oncology Network at Southside Cancer Center
		Michael R Olson	Ph: 904-202-7051
	Jacksonville Beach
	Florida Cancer Center - Beaches
		Michael R Olson	Ph: 904-202-7051
	Jascksonville
	Integrated Community Oncology Network - Baptist South
		Michael R Olson	Ph: 904-202-7051
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		Nagy Elsayyad	Ph: 866-574-5124
			Email: Sylvester@emergingmed.com
	Orange Park
	Integrated Community Oncology Network - Orange Park
		Michael R Olson	Ph: 904-202-7051
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Robert J Sollaccio	Ph: 407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Rafael R Manon	Ph: 321-841-7246
	Palatka
	Cancer Specialists of North Florida-Putnam
		Michael R Olson	Ph: 904-202-7051
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Gerald C Lowrey	Ph: 850-416-4611
	Saint Augustine
	Integrated Community Oncology Network at St. Augustine Cancer Center
		Michael R Olson	Ph: 904-202-7051
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Andy M. Trotti	Ph: 800-456-7121
			Email: canceranswers@moffitt.org
Georgia
	Atlanta
	Georgia Cancer Center for Excellence at Grady Memorial Hospital
		Kristin A Higgins	Ph: 404-778-1868
	Winship Cancer Institute of Emory University
		Kristin A Higgins	Ph: 404-778-1868
	Gainesville
	Northeast Georgia Medical Center
		Frank G. Lake	Ph: 770-219-8800
			Email: cancerpatient.navigator@nghs.com
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		John Raymond Duttenhaver	Ph: 912-350-8568
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		John A Pablo	Ph: 912-819-5704
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Samir Narayan	Ph: 734-712-3456
Illinois
	Arlington Heights
	Northwest Community Hospital
		Stephen S. Nigh	Ph: 847-618-4968
	Chicago
	Creticos Cancer Center at Advocate Illinois Masonic Medical Center
		Santosh V Yajnik	Ph: 847-384-3621
	John H. Stroger, Jr. Hospital of Cook County
		Fred R. Rosen	Ph: 312-864-6000
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Bharat B. Mittal	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	University of Chicago Cancer Research Center
		Daniel J Haraf	Ph: 773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Evanston
	CCOP - Evanston
		Bruce E. Brockstein	Ph: 847-570-1381
	Hines
	Veterans Affairs Medical Center - Hines
		Cheryl M Czerlanis	Ph: 708-226-4357
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Bahman Emami	Ph: 708-226-4357
	Springfield
	Cancer Institute at St. John's Hospital
		Cathy L. Clausen	Ph: 217-525-5666
			Email: diana.weyhenmeyer@st-johns.org
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard M. Gross	Ph: 317-783-8918
	Elkhart
	Elkhart General Hospital
		David A. Hornback	Ph: 800-284-7370
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		Brian K Chang	Ph: 260-373-8888
			Email: parkviewresearch@parkview.com
	Goshen
	Center for Cancer Care at Goshen General Hospital
		James A. Wheeler	Ph: 574-535-2858
	Indianapolis
	Community Regional Cancer Care at Community Hospital East
		Shih J Wei	Ph: 800-777-7775
	Community Regional Cancer Care at Community Hospital North
		Shih J Wei	Ph: 800-777-7775
	Mishawaka
	Michiana Hematology-Oncology, PC - Mishawaka
		David A. Hornback	Ph: 800-284-7370
	Muncie
	Cancer Center at Ball Memorial Hospital
		Yunjie X Lin	Ph: 765-751-5850
			Email: alpatterson@medicalconsultantspc.com
	South Bend
	Memorial Hospital of South Bend
		David A. Hornback	Ph: 800-284-7370
Iowa
	Ames
	McFarland Clinic, PC
		Joseph James Merchant	Ph: 515-239-2621
	Des Moines
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert J Behrens	Ph: 888-244-6061
			Email: sherrijr@iora.org
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Parvesh Kumar	Ph: 913-588-4709
	Overland Park
	Kansas City Cancer Centers - Southwest
		Parvesh Kumar	Ph: 913-588-4709
	Prairie Village
	CCOP - Kansas City
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Mahesh Kudrimoti	Ph: 859-257-3379
	Louisville
	University of Louisville School of Medicine
		Shiao Y Woo	Ph: 866-530-5516
Louisiana
	Baton Rouge
	Mary Bird Perkins Cancer Center - Baton Rouge
		Robert W Veith	Ph: 504-568-3410
			Email: aconne1@lsuhsc.edu
	New Orleans
	CCOP - Ochsner
		Mini J Elnaggar	Ph: 888-562-4763
Maine
	Scarborough
	Maine Medical Center- Scarborough Campus
		Ian J Bristol	Ph: 207-396-8090
			Email: wrighd@mmc.org
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Mohan Suntharalingam	Ph: 800-888-8823
	St. Agnes Hospital Cancer Center
		Richard S. Hudes	Ph: 410-368-2910
	Columbia
	Central Maryland Oncology Center
		Mohan Suntharalingam	Ph: 800-888-8823
Massachusetts
	Burlington
	Lahey Clinic Medical Center - Burlington
		Francis W. Nugent	Ph: 781-744-8027
	Fall River
	Hudner Oncology Center at Saint Anne's Hospital - Fall River
		Jason Lee	Ph: 617-724-5200
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: 734-712-3456
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Gilbert D Padula	Ph: 616-685-5225
	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: 734-712-3456
	Flint
	Genesys Hurley Cancer Institute
		Samir Narayan	Ph: 734-712-3456
		Samir Narayan	Ph: 734-712-3456
	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
		Raymond Sterling Lord	Ph: 269-373-7458
	Livonia
	St. Mary Mercy Hospital
		Samir Narayan	Ph: 734-712-3456
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Samir Narayan	Ph: 734-712-3456
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Daniel J Krauss	Ph: 248-551-7695
	Warren
	St. John Macomb Hospital
		Samir Narayan	Ph: 734-712-3456
Minnesota
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Edina
	Fairview Southdale Hospital
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Louis Park
	Park Nicollet Cancer Center
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Paul Sperduto	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		P. G. Shankar Giri	Ph: 601-815-6700
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James E. Clarkson	Ph: 228-809-5292
Missouri
	Cape Girardeau
	Cape Radiation Oncology
		Tapan Roy	Ph: 866-334-2230
			Email: sfmc@sfmc.net
	Kansas City
	Kansas City Cancer Centers - North
		Parvesh Kumar	Ph: 913-588-4709
	Kansas City Cancer Centers - South
		Parvesh Kumar	Ph: 913-588-4709
	Lee's Summit
	Kansas City Cancer Centers - East
		Parvesh Kumar	Ph: 913-588-4709
	Saint Louis
	Barnes-Jewish West County Hospital
		Wade L. Thorstad	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
	CCOP - St. Louis-Cape Girardeau
		Bethany G. Sleckman	Ph: 913-948-5588
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
	Saint Louis University Cancer Center
		Bruce J. Walz	Ph: 314-977-4440
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Wade L. Thorstad	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
	Springfield
	Hulston Cancer Center at Cox Medical Center South
		Robert L Carolla	Ph: 417-269-4520
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew W Huang	Ph: 402-354-5144
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Weining K. Zhen	Ph: 402-559-8555
			Email: llarson@unmc.edu
Nevada
	Las Vegas
	Radiation Oncology Centers of Las Vegas - Downtown Location
		Raul T Meoz	Ph: 702-731-8274
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Daniel W Weed	Ph: 775-982-4400
New Hampshire
	Concord
	Payson Center for Cancer Care at Concord Hospital
		Su K Metcalfe	Ph: 800-441-1138
	Dover
	Seacoast Cancer Center at Wentworth - Douglass Hospital
		Su K Metcalfe	Ph: 800-441-1138
	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
		Sucha O Asbell	Ph: 856-325-6757
	Long Branch
	Monmouth Medical Center
		Mitchell F Weiss	Ph: 732-923-7689
	Mount Holly
	Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
		Lemuel S. Ariaratnam	Ph: 888-847-8823
	Newark
	UMDNJ University Hospital
		A. Dolly Razdan	Ph: 732-235-8675
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Voichita Bar Ad	Ph: 215-955-6084
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Sucha O Asbell	Ph: 856-325-6757
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Thomas M Schroeder	Ph: 505-272-6972
New York
	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
	Syracuse
	SUNY Upstate Medical University Hospital
		Michael A Lacombe	Ph: 315-464-5476
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Christopher H Chay	Ph: 828-213-4150
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Anthony J Crimaldi	Ph: 704-355-2884
	Greensboro
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital
		Matthew A Manning	Ph: 336-832-0821
	Kinston
	Kinston Medical Specialists
		Peter R. Watson	Ph: 252-559-2200
	Monroe
	Edwards Cancer Center at Union Regional Medical Center
		Anthony J Crimaldi	Ph: 704-355-2884
	Pinehurst
	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
		Charles S Kuzma	Ph: 910-715-2200
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Charles A Kunos	Ph: 800-641-2422
	Barberton
	Barberton Citizens Hospital
		Charles A Kunos	Ph: 800-641-2422
	Cincinnati
	University of Cincinnati
		Kevin P. Redmond	Ph: 513-558-4553
			Email: uchealthnews@uc.edu
	Cleveland
	Case Comprehensive Cancer Center
		Min Yao	Ph: 800-641-2422
	Cleveland Clinic Cancer Center at Fairview Hospital
		David J Adelstein	Ph: 866-223-8100
	Cleveland Clinic Taussig Cancer Center
		David J Adelstein	Ph: 866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Maura L Gillison	Ph: 866-627-7616
			Email: osu@emergingmed.com
	Maumee
	Northwest Ohio Oncology Center
		Rex B Mowat	Ph: 517-265-0116
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		David J Adelstein	Ph: 866-223-8100
	Mentor
	Lake/University Ireland Cancer Center
		Min Yao	Ph: 800-641-2422
	Middleburg Heights
	Southwest General Health Center
		Min Yao	Ph: 800-641-2422
	Oregon
	St. Charles Mercy Hospital
		Rex B Mowat	Ph: 517-265-0116
	Salem
	Cancer Care Center, Incorporated
		William F. Demas	Ph: 330-615-4132
	Sandusky
	North Coast Cancer Care, Incorporated
		David J Adelstein	Ph: 866-223-8100
	Sylvania
	Flower Hospital Cancer Center
		Rex B Mowat	Ph: 517-265-0116
	Toledo
	St. Anne Mercy Hospital
		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
		Min Yao	Ph: 800-641-2422
	Wooster
	Cancer Treatment Center
		William F. Demas	Ph: 330-615-4132
	Cleveland Clinic - Wooster
		David J Adelstein	Ph: 866-223-8100
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Terence S. Herman	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Charles E Stewart	Ph: 918-494-2200
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Matthew C Solhjem	Ph: 503-215-6412
	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
	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
	Clairton
	UPMC Cancer Center at Jefferson Regional Medical Center
		James P Ohr	Ph: 412-647-8073
	East Stroudsburg
	Dale and Frances Hughes Cancer Center at Pocono Medical Center
		Voichita Bar Ad	Ph: 215-955-6084
	Gettysburg
	Adams Cancer Center
		Amit B. Shah	Ph: 877-441-7957
	Greensburg
	UPMC Cancer Center - Arnold Palmer Pavilion
		James P Ohr	Ph: 412-647-8073
	Hanover
	Cherry Tree Cancer Center
		Amit B. Shah	Ph: 877-441-7957
	Lancaster
	Lancaster General Hospital
		Jeffery S Eshleman	Ph: 717-544-5511
	Langhorne
	St. Mary Regional Cancer Center
		Robert C. Reilly	Ph: 215-710-4585
	Moon Township
	UPMC - Moon
		James P Ohr	Ph: 412-647-8073
	New Castle
	Jameson Memorial Hospital - North Campus
		James P Ohr	Ph: 412-647-8073
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Alexander Lin	Ph: 412-647-8073
	Fox Chase Cancer Center - Philadelphia
		Thomas J Galloway	Ph: 215-728-4790
	Pittsburgh
	St. Clair Memorial Hospital Cancer Center
		James P Ohr	Ph: 412-647-8073
	UPMC - Shadyside
		James P Ohr	Ph: 412-647-8073
	UPMC Cancer Center at UPMC Passavant
		James P Ohr	Ph: 412-647-8073
	UPMC Cancer Center at UPMC St. Margaret
		James P Ohr	Ph: 412-647-8073
	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
Rhode Island
	Providence
	Roger Williams Medical Center
		Mohit S Kasibhatla	Ph: 401-456-2268
			Email: rdavies@rwmc.org
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Paul E O'Brien	Ph: 843-792-9321
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		David L Grisell	Ph: 864-241-6251
	CCOP - Greenville
		David L Grisell	Ph: 864-241-6251
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		David L Grisell	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
	Nashville
	Vanderbilt-Ingram Cancer Center
		Kenneth J Niermann	Ph: 800-811-8480
Texas
	Galveston
	University of Texas Medical Branch
		Todd A Swanson	Ph: 409-772-1950
			Email: clinical.research@utmb.edu
	Houston
	Univeristy of Texas M.D. Anderson Cancer Center
		Jack Phan	Ph: 713-792-3245
Utah
	Logan
	Logan Regional Hospital
		Vilija N Avizonis	Ph: 801-507-3950
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		Vilija N Avizonis	Ph: 801-507-3950
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		Vilija N Avizonis	Ph: 801-507-3950
	Provo
	Utah Valley Regional Medical Center - Provo
		Vilija N Avizonis	Ph: 801-507-3950
	Saint George
	Dixie Regional Medical Center - East Campus
		Vilija N Avizonis	Ph: 801-507-3950
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Ying J Hitchcock	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Utah Cancer Specialists at UCS Cancer Center
		Vilija N Avizonis	Ph: 801-507-3950
Virginia
	Danville
	Danville Regional Medical Center
		Kiran Patel	Ph: 434-799-3753
	Norfolk
	Sentara Cancer Institute at Sentara Norfolk General Hospital
		Scott S Williams	Ph: 757-388-2406
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Douglas W Arthur	Ph: 804-628-1939
	Virginia Beach
	Coastal Cancer Center at Sentara Virginia Beach General Hospital
		Scott S Williams	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
		Huong T. Pham	Ph: 800-354-9527
	Seattle
	CCOP - Virginia Mason Research Center
		Huong T. Pham	Ph: 800-354-9527
	Vancouver
	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
	Yakima
	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
		Sean F. Cleary	Ph: 877-902-3324
West Virginia
	Huntington
	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
		Maria-Rosalia B. Tria Tirona	Ph: 304-399-6617
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Mohammed Almubarak	Ph: 304-293-2745
			Email: sfilburn@hsc.wvu.edu
Wisconsin
	Antigo
	Langlade Memorial Hospital
		Darryl R. Barton	Ph: 877-405-6866
	Appleton
	Fox Valley Surgical Associates at Appleton Medical Center
		Nathan D Munson	Ph: 920-380-1500
	Green Bay
	St. Mary's Hospital Medical Center - Green Bay
		Gregory M. Cooley	Ph: 920-433-8889
	St. Vincent Hospital Regional Cancer Center
		Gregory M. Cooley	Ph: 920-433-8889
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Collin D Driscoll	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Paul M. Harari	Ph: 877-405-6866
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Gregory M. Cooley	Ph: 920-433-8889
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Christopher J. Schultz	Ph: 414-805-4380
	Veterans Affairs Medical Center - Milwaukee
		Elizabeth M. Gore	Ph: 888-469-6614
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Darryl R. Barton	Ph: 877-405-6866
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Harold Lau	Ph: 403-521-3433
Manitoba
	Winnipeg
	CancerCare Manitoba
		James B. Butler	Ph: 866-561-1026
			Email: CIO_Web@cancercare.mb.ca
New Brunswick
	Saint John
	Saint John Regional Hospital
		Farah Naz	Ph: 506-648-6890
Ontario
	Ottawa
	Ottawa Hospital Regional Cancer Centre - Civic Campus
		Laval J Grimard	Ph: 613-761-4395
			Email: info@ohri.ca
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Louise Lambert	Ph: 514-890-8000ext23611
			Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca
	McGill Cancer Centre at McGill University
		George Shenouda	Ph: 514-934-1934ext42953
			Email: evelyn.ortega@muhc.mcgill.ca
	Quebec City
	Centre Hospitalier Universitaire de Quebec
		Andre Fortin	Ph: 418-525-4444
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Evgeny Sadikov	Ph: 306-766-2213
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Bryan L Brunet	Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01302834
Information obtained from ClinicalTrials.gov on November 20, 2012

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