Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentActive18 and overNCI, OtherRTOG 0920
CDR0000651536, NCI-2011-00878, NCT00956007

Trial Description

Summary

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. 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 when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

Further Study Information

OBJECTIVES:

Primary

  • Determine whether the addition of cetuximab to postoperative intensity-modulated radiotherapy (IMRT) will improve overall survival (OS) in patients with locally advanced squamous cell carcinoma of the head and neck at intermediate risk following surgery.

Secondary

  • Assess the impact of the addition of cetuximab to postoperative IMRT on disease-free survival (DFS) of these patients.
  • Assess the impact of the addition of cetuximab to postoperative IMRT on acute and late dysphagia, xerostomia, skin toxicity, and other toxicities according to common Toxicity Criteria for Adverse Effects (CTCAE), v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months.
  • Analyze tumor for epidermal growth factor receptor (EGFR), specifically the extent of EGFR overexpression by immuno-histochemistry (IHC) and FISH analysis, EGFRvIII expression, as well as the association of these assay data with OS and DFS.
  • Analyze tumor for human papillomavirus (HPV) infection (as defined by in situ hybridization), specifically, within the cohort of patients with oropharynx cancer, to perform an exploratory analysis of the impact of HPV on DFS and OS of this patient subset.
  • Analyze tumor DNA for TP53 mutations as a predictor of response to cetuximab and prognosis.
  • Analyze germline DNA of polymorphic variants in EGFR intron repeats as a predictor of response to cetuximab.

Tertiary

  • Assess the impact of the addition of cetuximab to postoperative IMRT on loco-regional control.
  • Assess the impact of the addition of cetuximab to postoperative IMRT on patient-reported quality of life, swallowing, xerostomia, and skin toxicity based on head and neck specific instruments, including the Performance Status Scale for Head and Neck Cancer (PSS-HN), the Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N), the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS), and the Dermatology Life Quality Index (DLQI).
  • Assess the impact of the addition of cetuximab to postoperative IMRT on cost-utility analysis using the EuroQol (EQ-5D).
  • Evaluate the utility of image-guided radiotherapy (IGRT) as a means of enhancing the efficacy (i.e., loco-regional control) of IMRT while reducing the acute and/or late toxicity (particularly xerostomia) and improving patient-reported outcomes (particularly XeQOLS scores).
  • Retrospectively compare the loco-regional control rate in patients treated with IMRT alone (no IGRT or cetuximab) with similar patients treated with external beam radiotherapy alone in the postoperative clinical trial Radiation Therapy Oncology Group (RTOG)-95 01.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical stage (T2-3 vs T4a), EGFR expression (high [≥ 80% of cells staining positive] vs low [< 80% of cells staining positive] vs not evaluable), primary site of disease (oral cavity vs larynx vs oropharynx p16+ vs oropharynx p16- vs oropharynx, p16 not evaluable), and use of image-guided radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at 3, 12, and 24 months.

Tissue samples are collected periodically for further laboratory analysis.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma (including variants, such as verrucous carcinoma, spindle cell carcinoma, or carcinoma not otherwise specified) of the head and neck, including the following subtypes:
  • Oral cavity
  • Oropharynx
  • Larynx
  • Clinical stage T1, N1-2, M0 OR T2-4a, N0-2, M0 disease based on the following diagnostic workup within the past 8 weeks:
  • General history and physical examination by a Radiation Oncologist and/or Medical Oncologist
  • Chest x-ray or chest CT scan (with or without contrast) or chest CT/PET scan (with or without contrast)
  • Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for "intermediate" risk of recurrence:
  • Perineural invasion
  • Lymphovascular invasion
  • Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) (no extracapsular extension)
  • Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible)
  • Pathologically confirmed T3 or T4a primary tumor
  • T2 oral cavity cancer with > 5 mm depth of invasion
  • No positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Total bilirubin < 2 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN
  • Serum creatinine < 2 times ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 3 years, except for nonmelanomatous skin cancer or previously treated carcinoma in situ of the breast, oral cavity, or cervix
  • No simultaneous primary or bilateral tumors
  • No severe, active co-morbidity, including 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 IV antibiotics at the time of study registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to have required oxygen therapy within the past year
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS based on current Centers for Disease Control (CDC) definition
  • Grade 3-4 electrolyte abnormalities according to CTCAE, v. 4, including any of the following:
  • Serum calcium (ionized or adjusted for albumin) < 7 mg/dL or > 12.5 mg/dL*
  • Glucose < 40 mg/dL or > 250 mg/dL
  • Magnesium < 0.9 mg/dL or > 3 mg/dL*
  • Potassium < 3.5 mmol/L or > 6 mmol/L*
  • Sodium < 130 mmol/L or > 155 mmol/L* NOTE: *Despite intervention to normalize levels.
  • No prior allergic reaction to cetuximab

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for this cancer
  • Prior chemotherapy or anti-EGF therapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • 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

  • National Cancer Institute
  • NRG Oncology
Mitchell Machtay, Study Chair

Trial Sites

U.S.A.

Alabama
Birmingham

UAB Comprehensive Cancer Center

Sharon A Spencer
Ph: 205-934-0309

Arizona
Tucson

Arizona Oncology - Tucson

Vivek S Kavadi
Ph: 281-277-5200

Arkansas
Little Rock

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Matthew E Hardee
Ph: 501-686-8274

California
Auburn

Auburn Radiation Oncology

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Cameron Park

Radiation Oncology Centers - Cameron Park

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.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

USC/Norris Comprehensive Cancer Center and Hospital

Eugene I Chung
Ph: 323-865-0451

Eugene I Chung
Ph: 323-865-0451

Modesto

Memorial Medical Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.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

Samantha A Seaward
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

Samantha A Seaward
Ph: 626-564-3455

Sacramento

Sutter Cancer Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

University of California Davis Cancer Center

Shyam S Rao
Ph: 916-734-3089

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

Samantha A Seaward
Ph: 626-564-3455

Vacaville

Solano Radiation Oncology Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Colorado
Aurora

Rocky Mountain Cancer Centers - Aurora

Keren Sturtz
Ph: 888-785-6789

University of Colorado Cancer Center at UC Health Sciences Center

David Raben
Ph: 720-848-0650

Colorado Springs

Penrose Cancer Center at Penrose Hospital

Keren Sturtz
Ph: 888-785-6789

Denver

Porter Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Englewood

Swedish Medical Center

Keren Sturtz
Ph: 888-785-6789

Littleton

Rocky Mountain Cancer Centers - Littleton

Keren Sturtz
Ph: 888-785-6789

Loveland

McKee Medical Center

Keren Sturtz
Ph: 888-785-6789

Connecticut
Bridgeport

St. Vincent's Medical Center

Christopher M Iannuzzi
Ph: 203-576-6329
Email: twhite@stvincents.org

Hartford

Helen and Harry Gray Cancer Center at Hartford Hospital

Neal B Goldberg
Ph: 860-224-5660

Middletown

Middlesex Hospital Cancer Center

Susanna Hong
Ph: 860-358-2058

New Haven

Yale Cancer Center

Zain A Husain
Ph: 203-785-5702

Norwich

William W. Backus Hospital

Dennis E. Slater
Ph: 860-886-8362

Delaware
Newark

Helen F. Graham Cancer Center at Christiana Hospital

Adam Raben
Ph: 302-733-6227

Florida
Deerfield Beach

University of Miami/Deerfield Beach

Michael A Samuels
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Miami

Baptist-South Miami Regional Cancer Program

Andre A. Abitbol
Ph: 800-599-2456
Email: cancerinfo@baptisthealth.net

University of Miami Sylvester Comprehensive Cancer Center - Miami

Michael A Samuels
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Orlando

M.D. Anderson Cancer Center at Orlando

Rafael R Manon
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Georgia
Atlanta

Winship Cancer Institute of Emory University

Jonathan J Beitler
Ph: 404-778-1868

Decatur

Veterans Affairs Medical Center - Atlanta (Decatur)

Bruce W Hershatter
Ph: 404-321-6111ext7632

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Aaron W Pederson
Ph: 912-350-8568

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

John A Pablo
Ph: 800-622-6877

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

Illinois
Chicago

John H. Stroger, Jr. Hospital of Cook County

Thomas E. Lad
Ph: 312-864-6000

University of Illinois Cancer Center

Lawrence Eric Feldman
Ph: 312-355-3046

Decatur

Decatur Memorial Hospital Cancer Care Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Harvey

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Sulochana D Yalavarthi
Ph: 708-915-4673
Email: clinicaltrials@ingalls.org

Hines

Veterans Affairs Medical Center - Hines

Cheryl M Czerlanis
Ph: 708-226-4357

Joliet

Joliet Oncology-Hematology Associates, Limited - West

Kulumani M Sivarajan
Ph: 815-730-3098
Email: maureenc@jolietoncology.com

Maywood

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Bahman Emami
Ph: 708-226-4357

Pekin

Cancer Treatment Center at Pekin Hospital

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Peoria

Methodist Medical Center of Illinois

Nguyet A Le-Lindqwister
Ph: 800-793-2262

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

Springfield

Cancer Institute at St. John's Hospital

Laurent Brard
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
Bloomington

Bloomington Hospital Regional Cancer Institute

Fred Y Wu
Ph: 812-353-2831

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

Community Regional Cancer Care at Community Hospital East

Shih J Wei
Ph: 317-621-7104

Community Regional Cancer Care at Community Hospital North

Shih J Wei
Ph: 317-621-7104

Methodist Cancer Center at Methodist Hospital

Alexander M. Yeh
Ph: 765-646-8358

Muncie

Cancer Center at Ball Memorial Hospital

Yunjie X Lin
Ph: 765-751-5850

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: 515-282-2921

Mercy Cancer Center at Mercy Medical Center - Des Moines

Mehmet S. Copur
Ph: 800-998-2119

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Mark C Smith
Ph: 800-237-1225

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

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

Augusto C Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

New Orleans

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

Mitchell Machtay
Ph: 800-641-2422
Email: mitchell.machtay@uhhospitals.org

Touro Infirmary

Augusto C Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Tulane Cancer Center at Tulane University Hospital and Clinic

William R. Robinson
Ph: 504-988-6121

Maryland
Baltimore

Greenebaum Cancer Center at University of Maryland Medical Center

Mohan Suntharalingam
Ph: 800-888-8823

Bel Air

Upper Chesapeake Medical Center

Mohan Suntharalingam
Ph: 800-888-8823

Salisbury

Peninsula Regional Medical Center

John R Mansueti
Ph: 866-922-6237

Massachusetts
Boston

Boston University Cancer Research Center

Minh T Truong
Ph: 617-638-8265

Burlington

Lahey Clinic Medical Center - Burlington

Francis W. Nugent
Ph: 781-744-8027

Pittsfield

Berkshire Hematology Oncology, PC

Harvey Zimbler
Ph: 413-496-8205
Email: ggero@bhs1.org

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Samir Narayan
Ph: 734-712-4673

Dearborn

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

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

Flint

McLaren Cancer Institute

Thomas P Boike
Ph: 800-248-6777

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Lapeer

Great Lakes Cancer Institute - Lapeer Campus

Thomas P Boike
Ph: 800-248-6777

Owosso

Great Lakes Cancer Institute - Owosso

Thomas P Boike
Ph: 800-248-6777

Pontiac

St. Joseph Mercy Oakland

Samir Narayan
Ph: 734-712-4673

Saginaw

Seton Cancer Institute at Saint Mary's - Saginaw

Samir Narayan
Ph: 734-712-4673

Warren

St. John Macomb Hospital

Samir Narayan
Ph: 734-712-4673

Minnesota
Coon Rapids

Mercy and Unity Cancer Center at Mercy Hospital

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Duluth

St. Luke's Hospital Cancer Care Center

Steven R Bonin
Ph: 888-823-5923
Email: ctsucontact@westat.com

Fridley

Mercy and Unity Cancer Center at Unity Hospital

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Maplewood

Minnesota Oncology - Maplewood

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Minneapolis

Veterans Affairs Medical Center - Minneapolis

Sharon D Luikart
Ph: 612-467-2800

Mississippi
Jackson

University of Mississippi Cancer Clinic

Shankar P Giri
Ph: 601-815-6700

Pascagoula

Regional Cancer Center at Singing River Hospital

James E. Clarkson
Ph: 228-809-5292

Missouri
Kansas City

Kansas City Cancer Centers - North

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

David C. Pratt Cancer Center at St. John's Mercy

Jay W Carlson
Ph: 800-821-7532

Missouri Baptist Cancer Center

Alan Philip Lyss
Ph: 800-392-0936

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Wade L. Thorstad
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Saint Peters

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

Wade L. Thorstad
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Springfield

Hulston Cancer Center at Cox Medical Center South

Jay W Carlson
Ph: 800-821-7532

St. John's Regional Health Center

Jay W Carlson
Ph: 800-821-7532

Nebraska
Lincoln

Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center

Mehmet S. Copur
Ph: 800-998-2119

Omaha

Fred and Pamela Buffett Cancer Center

Weining K. Zhen
Ph: 402-559-8555
Email: llarson@unmc.edu

Methodist Estabrook Cancer Center

Tien-Shew W Huang
Ph: 402-354-5144

New Hampshire
Exeter

Center for Cancer Care at Exeter Hospital

Gary Miller Proulx
Ph: 800-439-3837

Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Alan C. Hartford
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey
Basking Ridge

Memorial Sloan-Kettering Cancer Center - Basking Ridge

Nancy Lee
Ph: 212-639-7202

Camden

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Gregory J Kubicek
Ph: 856-325-6757

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

Rita Susan Axelrod
Ph: 215-955-6084

Voorhees

Cancer Institute of New Jersey at Cooper - Voorhees

Gregory J Kubicek
Ph: 856-325-6757

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Lemuel S. Ariaratnam
Ph: 888-847-8823

New Mexico
Albuquerque

University of New Mexico Cancer Center

Benny J. Liem
Ph: 505-272-6972

New York
Albany

New York Oncology Hematology, PC - Albany

Vivek S Kavadi
Ph: 281-277-5200

Brooklyn

Maimonides Cancer Center at Maimonides Medical Center

Jay S Cooper
Ph: 718-765-2500

Canandiaqua

Sands Cancer Center

Yuhchyau Chen
Ph: 585-275-5830

Glens Falls

Charles R. Wood Cancer Center at Glens Falls Hospital

John P Stoutenburg
Ph: 518-926-6700

New York

Beth Israel Medical Center - Petrie Division

Bruce E. Culliney
Ph: 212-844-6286

Memorial Sloan-Kettering Cancer Center

Nancy Lee
Ph: 212-639-7202

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

Syracuse

SUNY Upstate Medical University Hospital

Seung Shin Hahn
Ph: 315-464-5476

North Carolina
Asheville

Mission Hospitals - Memorial Campus

Christopher H Chay
Ph: 828-213-4150

Gastonia

CaroMont Cancer Center at Gaston Memorial Hospital

Charles J. Meakin
Ph: 704-834-2932

Kinston

Kinston Medical Specialists

Peter R. Watson
Ph: 252-559-2200

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Kathryn McConnell Greven
Ph: 336-713-6771

North Dakota
Bismarck

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

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

Beachwood

UHHS Chagrin Highlands Medical Center

Min Yao
Ph: 800-641-2422

Canton

Mercy Cancer Center at Mercy Medical Center

Edward J Walsh
Ph: 888-293-4673

Chardon

Geauga Regional Hospital

Min Yao
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: 800-293-5066
Email: Jamesline@osumc.edu

Elyria

Mercy Cancer Center - Elyria

Min Yao
Ph: 800-641-2422

Independence

Cleveland Clinic Taussig Cancer Center

David J Adelstein
Ph: 866-223-8100

Mayfield Heights

Hillcrest Cancer Center at Hillcrest Hospital

David J Adelstein
Ph: 866-223-8100

Medina

Summa Health Center at Lake Medina

Charles A Kunos
Ph: 330-375-6101

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: 800-444-3561

Parma

Parma Community General Hospital

Min Yao
Ph: 800-641-2422

Portsmouth

Southern Ohio Medical Center Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Ravenna

Robinson Radiation Oncology

Mitchell Lee Fromm
Ph: 330-344-6348

Sandusky

North Coast Cancer Care, Incorporated

David J Adelstein
Ph: 866-223-8100

Strongsville

Cleveland Clinic Foundation - Strongsville

David J Adelstein
Ph: 866-223-8100

Sylvania

Flower Hospital Cancer Center

Jeffrey H Muler
Ph: 419-824-1842

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

Cleveland Clinic - Wooster

David J Adelstein
Ph: 866-223-8100

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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
Email: Julie.Cramer@providence.org

Eugene

Willamette Valley Cancer Center - Eugene

Vivek S Kavadi
Ph: 281-277-5200

Portland

Providence Cancer Center at Providence Portland Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Providence St. Vincent Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Pennsylvania
Clairton

UPMC Cancer Center at Jefferson Regional Medical Center

Dwight E Heron
Ph: 412-647-8073

Danville

Geisinger Cancer Institute at Geisinger Health

Thomas J Gergel
Ph: 570-271-5251

Dunmore

Northeast Radiation Oncology Center

Rita Susan Axelrod
Ph: 215-955-6084

East Stroudsburg

Dale and Frances Hughes Cancer Center at Pocono Medical Center

Rita Susan Axelrod
Ph: 215-955-6084

Easton

Easton Regional Cancer Center at Easton Hospital

Sonyo Shin
Ph: 610-250-4000

Gettysburg

Adams Cancer Center

Amit B. Shah
Ph: 877-441-7957

Greensburg

UPMC Cancer Center - Arnold Palmer Pavilion

Dwight E Heron
Ph: 412-647-8073

Hanover

Cherry Tree Cancer Center

Amit B. Shah
Ph: 877-441-7957

Harrisburg

PinnacleHealth Regional Cancer Center at Polyclinic Hospital

Brij M Sood
Ph: 717-724-6765
Email: klitchfield@PINNACLEHEALTH.org

Johnstown

UPMC Cancer Center at the John P. Murtha Pavilion

Dwight E Heron
Ph: 412-647-8073

McKeesport

UPMC Cancer Center at UPMC McKeesport

Dwight E Heron
Ph: 412-647-8073

Philadelphia

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Rita Susan Axelrod
Ph: 215-955-6084

Pittsburgh

St. Clair Memorial Hospital Cancer Center

Dwight E Heron
Ph: 412-647-8073

UPMC - Shadyside

Dwight E Heron
Ph: 412-647-8073

UPMC Cancer Center at UPMC Passavant

Dwight E Heron
Ph: 412-647-8073

UPMC Cancer Center at UPMC St. Margaret

Dwight E Heron
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

South Carolina
Anderson

AnMed Cancer Center

Patricia C Griffin
Ph: 800-486-5941

Charleston

Hollings Cancer Center at Medical University of South Carolina

Anand Sharma
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

Greer

Cancer Centers of the Carolinas - Greer Radiation Oncology

David L Grisell
Ph: 864-241-6251

Gibbs Cancer Center-Pelham

Patricia C Griffin
Ph: 800-486-5941

Seneca

Cancer Centers of the Carolinas - Seneca

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

Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Preston D. Steen
Ph: 701-234-6161

Tennessee
Kingsport

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Asheesh Shipstone
Ph: 423-578-8538

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

Dallas

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Lucien A. Nedzi
Ph: 214-648-7097

Denton

Texas Oncology, PA at Texas Cancer Center - Denton South

Vivek S Kavadi
Ph: 281-277-5200

Flower Mound

Texas Oncology-Flower Mound

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

Ben Taub General Hospital

Mark D Bonnen
Ph: 713-798-1354
Email: burton@bcm.edu

Memorial Hermann Hospital - Memorial City

Vivek S Kavadi
Ph: 281-277-5200

Univeristy of Texas M.D. Anderson Cancer Center

Erich M Sturgis
Ph: 713-792-3245

Plano

Texas Oncology - Plano West 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

San Antonio

University of Texas Health Science Center at San Antonio

Ying Li
Ph: 210-450-3800
Email: CTO@uthscsa.edu

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

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

LDS Hospital

Vilija N Avizonis
Ph: 801-507-3950

Utah Cancer Specialists at UCS Cancer Center

Vilija N Avizonis
Ph: 801-507-3950

Virginia
Charlottesville

University of Virginia Cancer Center

Paul W Read
Ph: 434-243-6143

Hampton

Sentara Cancer Institute at Sentara CarePlex Hospital

Scott S Williams
Ph: 757-388-2406

Norfolk

Sentara Cancer Institute at Sentara Norfolk General Hospital

Scott S Williams
Ph: 757-388-2406

Virginia Beach

Coastal Cancer Center at Sentara Virginia Beach General Hospital

Scott S Williams
Ph: 757-388-2406

Washington
Kennewick

Tri-Cities Cancer Center

George E. Laramore
Ph: 206-616-8289

Mount Vernon

Skagit Valley Hospital Cancer Care Center

George E. Laramore
Ph: 206-616-8289

Seattle

University Cancer Center at University of Washington Medical Center

George E. Laramore
Ph: 206-616-8289

Spokane

Cancer Care Northwest - North

Vivek S Kavadi
Ph: 281-277-5200

Cancer Care Northwest - Spokane South

Vivek S Kavadi
Ph: 281-277-5200

Vancouver

Northwest Cancer Specialists at Vancouver Cancer Center

Vivek S Kavadi
Ph: 281-277-5200

Southwest Washington Medical Center Cancer Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Wenatchee

Confluence Health - Wenatchee Valley Medical Center

George E. Laramore
Ph: 206-616-8289

West Virginia
Morgantown

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Manish Monga
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Wheeling

Schiffler Cancer Center at Wheeling Hospital

Jon David Pollock
Ph: 304-243-6442

Wisconsin
Antigo

Langlade Memorial Hospital

Darryl R. Barton
Ph: 877-405-6866

Appleton

Fox Valley Hematology and Oncology - East Grant Street

Robert R Kohl
Ph: 920-433-8889

Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Paul M. Harari
Ph: 877-405-6866

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Christopher J. Schultz
Ph: 414-805-4380

Veterans Affairs Medical Center - Milwaukee

Elizabeth M. Gore
Ph: 414-805-4380

Wausau

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Darryl R. Barton
Ph: 877-405-6866

Canada

Alberta
Edmonton

Cross Cancer Institute at University of Alberta

Rufus A Scrimger
Ph: 780-432-8500

Ontario
Ottawa

Ottawa Hospital Regional Cancer Centre - General Campus

Samy El-Sayed
Ph: 613-761-4395
Email: info@ohri.ca

Sudbury

Northeastern Ontario Regional Cancer Centre

David A Want
Ph: 706-522-6237ext2401
Email: japaquette@hrsrh.on.ca

Toronto

Princess Margaret Hospital

John (Joon-Hyung) Kim
Ph: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec
Montreal

McGill Cancer Centre at McGill University

George Shenouda
Ph: 514-934-1934ext42953
Email: evelyn.ortega@muhc.mcgill.ca

Sherbrooke

CHUS-Hopital Fleurimont

Chang S Wang
Ph: 819-820-6480
Email: crcinformation.chus@ssss.gouv.qc.ca

Saskatchewan
Regina

Allan Blair Cancer Centre at Pasqua Hospital

Evgeny Sadikov
Ph: 306-766-2213

China

Hong Kong
Shatin

Prince of Wales Hospital

Michael K Kam
Ph: 888-823-5923
Email: ctsucontact@westat.com

Saudi Arabia

Riyadh

King Faisal Specialist Hospital and Research Center

Nasser M Al-Rajhi
Ph: 011-966-1-464-7272 ext 38005

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00956007
ClinicalTrials.gov processed this data on March 23, 2015

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.