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Clinical Trials (PDQ®)

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

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

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

Mitchell MachtayStudy 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
California
  Auburn
 Auburn Radiation Oncology
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@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
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Sacramento
 Sutter Cancer Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@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
  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
  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
Connecticut
  Bridgeport
 St. Vincent's Medical Center
 Christopher M Iannuzzi Ph: 203-576-6329
  Email: twhite@stvincents.org
  New Haven
 Yale Cancer Center
 Roy H Decker 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
  Jacksonville
 Mayo Clinic - Jacksonville
 Robert L. Foote Ph: 507-538-7623
  Miami
 Baptist-South Miami Regional Cancer Program
 Andre A. Abitbol Ph: 800-599-2456
  Email: cancerinfo@baptisthealth.net
  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
  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
 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
 Fred R. Rosen Ph: 312-864-6000
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Eric D Donnelly Ph: 312-695-1301
  Email: cancer@northwestern.edu
  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
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Bahman Emami Ph: 708-226-4357
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Springfield
 Cancer Institute at St. John's Hospital
 Laurent Brard Ph: 217-545-7929
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  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
  Email: alpatterson@medicalconsultantspc.com
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
  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
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
 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
 Robert W Veith 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
  Salisbury
 Peninsula Regional Medical Center
 Matthew L Snyder 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
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-4673
 University of Michigan Comprehensive Cancer Center
 Avraham Eisbruch Ph: 800-865-1125
  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
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  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
  Rochester
 Mayo Clinic Cancer Center
 Robert L. Foote Ph: 507-538-7623
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
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Donald C Doll Ph: 573-882-7440
  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
  Email: sherrijr@iora.org
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 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
  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
  Email: sherrijr@iora.org
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
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
  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
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
  New York
 Beth Israel Medical Center - Petrie Division
 Kenneth Hu Ph: 212-844-6286
  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
 Seung Shin Hahn Ph: 315-464-5476
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Christopher H Chay Ph: 828-213-4150
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Bhishamjit S Chera Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  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
  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
  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
  Elyria
 Mercy Cancer Center - Elyria
 Min Yao Ph: 800-641-2422
  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
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  West Chester
 University Pointe
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Westlake
 UHHS Westlake Medical Center
 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
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Matthew C Solhjem Ph: 503-215-6412
  Eugene
 Willamette Valley Cancer Center - Eugene
 Vivek S Kavadi Ph: 281-277-5200
  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
 Veterans Affairs Medical Center - Portland
 Neil D Gross Ph: 503-494-1080
  Email: trials@ohsu.edu
  Salem
 Salem Hospital Regional Cancer Care Services
 Matthew Seth Gordon Ph: 503-561-2618
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Lawrence Friedman Ph: 610-402-2273
  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
  Gettysburg
 Adams Cancer Center
 Amit B. Shah Ph: 877-441-7957
  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
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Rita Susan Axelrod Ph: 215-955-6084
  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
 Gibbs Cancer Center-Pelham
 Patricia C Griffin Ph: 800-486-5941
  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
 Miroslaw A Mazurczak Ph: 605-328-1367
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
  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
  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: 210-567-0653
  Email: che@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
  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
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Harry D. Bear Ph: 804-628-1939
  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
 Southwest Washington Medical Center Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
  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
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 Gregory M. Cooley Ph: 920-699-3500
  Email: lynda.persico@uwmf.wisc.edu
  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: 920-699-3500
  Email: lynda.persico@uwmf.wisc.edu
  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
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 Gregory M. Cooley Ph: 920-699-3500
  Email: lynda.persico@uwmf.wisc.edu
  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
  Sudbury
 Northeastern Ontario Regional Cancer Centre
 Adam K Andronowski Ph: 706-522-6237ext2401
  Email: japaquette@hrsrh.on.ca
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Edith J Filion 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
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 Evgeny Sadikov Ph: 306-766-2213

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00956007
ClinicalTrials.gov processed this data on May 28, 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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