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Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherRTOG-1016
CDR0000695731, NCT01302834

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

National Cancer Institute

Andy M. TrottiPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Kirklin Clinic at Acton Road
 Sharon A Spencer Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 Sharon A Spencer Ph: 205-934-0309
Arizona
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Sun K Yi Ph: 520-626-9008
California
  Auburn
 Auburn Radiation Oncology
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Burlingame
 Peninsula Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Los Angeles
 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
 Jorge A Garcia-Young Ph: 209-572-7116
  Oakland
 Kaiser Permanente-Oakland
 Samantha A Seaward Ph: 626-564-3455
  Paradise
 Feather River Hospital Cancer Center
 Sam Mazj Ph: 530-876-7995
  Email: haleew@ah.org
  Rancho Cardova
 Kaiser Permanente Medical Center - Rancho Cordova
 Samantha A Seaward Ph: 626-564-3455
  Rohnert Park
 Rohnert Park Cancer Center
 Samantha A Seaward Ph: 626-564-3455
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
 The Permanente Medical Group-Roseville Radiation Oncology
 Samantha A Seaward Ph: 626-564-3455
  Sacramento
 Radiological Associates of Sacramento Medical Group, Incorporated
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
 South Sacramento Cancer Center
 Samantha A Seaward 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
 Samantha A Seaward Ph: 626-564-3455
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Cancer Treatment Center
 Samantha A Seaward 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: 916-454-6500
  Email: cancerinfo@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
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Alan T Monroe 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
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Keren Sturtz 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
  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
  Jascksonville
 Integrated Community Oncology Network - Baptist South
 Michael R Olson Ph: 904-202-7051
  Orange Park
 Integrated Community Oncology Network - Orange Park
 Michael R Olson Ph: 904-202-7051
  Orlando
 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
 Jonathan J Beitler Ph: 404-778-1868
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: phri@piedmont.org
 Winship Cancer Institute of Emory University
 Jonathan J Beitler Ph: 404-778-1868
  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
  Chicago
 Creticos Cancer Center at Advocate Illinois Masonic Medical Center
 Santosh V Yajnik Ph: 773-296-5360
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Bharat B. Mittal Ph: 312-695-1301
  Email: cancer@northwestern.edu
  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
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 317-783-8918
  Goshen
 Center for Cancer Care at Goshen General Hospital
 James A. Wheeler Ph: 574-535-2858
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  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
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
 Robert W Veith Ph: 504-568-2428
  Email: emede1@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
  Boston
 Tufts Medical Center Cancer Center
 Miriam O'Leary Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Burlington
 Lahey Clinic Medical Center - Burlington
 Francis W. Nugent Ph: 781-744-8027
Michigan
  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
  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
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-3456
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 P. G. Shankar Giri Ph: 601-815-6700
Missouri
  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
 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
 Wade L. Thorstad 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
 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
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Michael C Hardacre Ph: 317-356-2422
New Hampshire
  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
 Sabin B Motwani 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
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
  Concord
 Batte Cancer Center at Northeast 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
Ohio
  Akron
 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
  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
  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
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Min Yao Ph: 800-641-2422
  Sandusky
 North Coast Cancer Care, Incorporated
 David J Adelstein Ph: 866-223-8100
  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
 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
  Grants Pass
 Three Rivers Community Hospital
 Gordon L. Metz Ph: 541-789-6176
  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 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
  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
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Voichita Bar Ad Ph: 215-955-6084
  Pittsburgh
 Allegheny Cancer Center at Allegheny General Hospital
 Youssef M Arshoun Ph: 724-226-7380
 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
South Carolina
  Anderson
 AnMed Cancer Center
 Patricia C Griffin Ph: 800-486-5941
  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
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 Paul E O'Brien Ph: 843-792-9321
  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
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 Kenneth J Niermann Ph: 800-811-8480
Texas
  Galveston
 University of Texas Medical Branch
 Lee R Wiederhold 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
Vermont
  Saint Johnsbury
 Norris Cotton Cancer Center - North
 Alan C. Hartford Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
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
  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
 Yoshio Inoue Ph: 253-403-2394
  Seattle
 CCOP - Virginia Mason Research Center
 Huong T. Pham Ph: 800-354-9527
  Tacoma
 CCOP - Northwest
 Yoshio Inoue Ph: 253-403-2394
  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
 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
  Green Bay
 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
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel 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
 James L Leenstra Ph: 920-433-8889
  Menomonee Falls
 Community Memorial Hospital Cancer Care Center
 Christopher J. Schultz Ph: 414-805-4380
  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
  London
 London Regional Cancer Program at London Health Sciences Centre
 David Palma Ph: 519-685-8600
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
  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
  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
ClinicalTrials.gov processed this data on January 07, 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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