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

Basic Trial Information

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 CTCAE, v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months.

• Analyze tumor for EGFR, specifically the extent of EGFR overexpression by 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 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)

• AST or 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 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-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

Mitchell Machtay

Study Chair

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph: 205-934-0309
Arizona
	Tucson
	Arizona Oncology - Tucson
		Vivek S. Kavadi	Ph: 520-797-4468
California
	Auburn
	Auburn Radiation Oncology
		Christopher Jones, MD	Ph: 916-646-6600
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Christopher Jones, MD	Ph: 916-646-6600
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Christopher Jones, MD	Ph: 916-646-6600
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Cen	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
	Modesto
	Memorial Medical Center
		Clinical Trials Office - Memorial Medical Center	Ph: 209-572-7116
	Roseville
	Radiation Oncology Center - Roseville
		Christopher Jones, MD	Ph: 916-646-6600
	Sacramento
	Mercy General Hospital
		Christopher Jones, MD	Ph: 916-646-6600
	Radiological Associates of Sacramento Medical Group, Incorporated
		Christopher Jones, MD	Ph: 916-646-6600
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer	Ph: 916-734-3089
	Saint Helena
	Saint Helena Hospital
		David J. Tate	Ph: 707-963-3611
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensi	Ph: 877-827-3222
	Vacaville
	Solano Radiation Oncology Center
		Christopher Jones, MD	Ph: 916-646-6600
Colorado
	Aurora
	Rocky Mountain Cancer Centers - Aurora
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
	University of Colorado Cancer Center at UC Health Sciences Center
		Clinical Trials Office - University of Colorado Cancer Center	Ph: 720-848-0650
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph: 719-776-5275
	Denver
	Porter Adventist Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020ext2261
Connecticut
	Bridgeport
	St. Vincent's Medical Center
		Christopher M. Iannuzzi	Ph: 203-576-6000
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph: 203-785-5702
	Norwich
	William W. Backus Hospital
		Dennis E. Slater, MD	Ph: 860-886-8362
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph: 302-623-4450
Florida
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph: 407-303-5623
Georgia
	Atlanta
	Emory Crawford Long Hospital
		Jonathan J. Beitler	Ph: 404-686-4411
	Winship Cancer Institute of Emory University
		Clinical Trials Office - Winship Cancer Institute	Ph: 404-778-1900
	Savannah
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		John A. Pablo	Ph: 912-819-6000
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph: 808-586-2979
	Hawaii Medical Center - East
		Paul A. DeMare, MD, FACR	Ph: 808-547-4771
	Queen's Cancer Institute at Queen's Medical Center
		Paul A. DeMare, MD, FACR	Ph: 808-547-4771
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph: 208-367-7954
Illinois
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls	Ph: 708-915-4673
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph: 708-226-4357
	Springfield
	Cancer Institute at St. John's Hospital
		Cathy L. Clausen, MD	Ph: 765-646-8358
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph: 800-446-5532
Indiana
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		Brian K. Chang	Ph: 260-373-7850
	Radiation Oncology Associates Southwest
		Brian K. Chang	Ph: 260-436-4116
	Goshen
	Center for Cancer Care at Goshen General Hospital
		Clinical Trials Office - Center for Cancer Care at Goshen Gene	Ph: 574-535-2858
	Indianapolis
	Community Regional Cancer Care at Community Hospital East
		Shih J. Wei	Ph: 317-355-5347
	Community Regional Cancer Care at Community Hospital North
		Shih J. Wei	Ph: 317-621-4300
	Muncie
	Cancer Center at Ball Memorial Hospital
		Clinical Trials Office - Cancer Center at Ball Memorial Hospit	Ph: 765-281-2107
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph: 515-239-2621
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald B. Wender, MD, PhD	Ph: 712-252-0088
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Instit	Ph: 913-588-4709
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of	Ph: 859-257-3379
	Louisville
	James Graham Brown Cancer Center at University of Louisville
		Shiao Y. Woo	Ph: 502-562-4158
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph: 504-988-6121
Maine
	Lewiston
	Central Maine Comprehensive Cancer Center at Central Maine Medical Center
		Courtney A. Jensen	Ph: 207-795-2440
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Cen	Ph: 617-638-8265
	Burlington
	Lahey Clinic Medical Center - Burlington
		Clinical Trials Office - Lahey Clinic Medical Center - Burling	Ph: 781-744-8027
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive	Ph: 800-865-1125
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph: 269-373-7458
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph: 989-776-8411
Minnesota
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Paul Sperduto, MD, MAPP	Ph: 952-442-6000
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Paul Sperduto, MD, MAPP	Ph: 952-442-6000
	Maplewood
	Minnesota Oncology - Maplewood
		Paul Sperduto, MD, MAPP	Ph: 952-442-6000
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph: 507-538-7623
Mississippi
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James E. Clarkson, MD	Ph: 228-374-6296
Missouri
	Cape Girardeau
	Cancer Institute of Cape Girardeau, LLC
		Tapan Roy, MD	Ph: 573-334-2230
	Saint Louis
	Barnes-Jewish West County Hospital
		Wade L. Thorstad, MD	Ph: 314-362-8516
	Missouri Baptist Cancer Center
		Alan P. Lyss, MD	Ph: 314-996-5514
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Wade L. Thorstad, MD	Ph: 314-362-8516
	Saint Peters
	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
		Wade L. Thorstad, MD	Ph: 314-362-8516
	Springfield
	Hulston Cancer Center at Cox Medical Center South
		Robert L. Carolla	Ph: 417-269-5257
Nebraska
	Lincoln
	Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
		Clinical Trials Office - Saint Elizabeth Cancer Institute at S	Ph: 402-483-2827
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew W. Huang	Ph: 402-354-5890
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Weining K. Zhen, MD	Ph: 402-552-3844
Nevada
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Daniel W. Weed	Ph: 775-982-5050
New Hampshire
	Exeter
	Center for Cancer Care at Exeter Hospital
		Gary M. Proulx	Ph: 570-882-4048
New Jersey
	Basking Ridge
	Memorial Sloan-Kettering Cancer Center - Basking Ridge
		Nancy Lee, MD	Ph: 212-639-3341
	New Brunswick
	Saint Peter's University Hospital
		Gopal R. Desai	Ph: 732-745-8600
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Rita S. Axelrod, MD	Ph: 215-955-8874
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Cente	Ph: 505-272-6972
New York
	Albany
	New York Oncology Hematology, PC at Albany Regional Cancer Care
		Vivek S. Kavadi	Ph: 518-489-2607
	Canandiaqua
	Sands Cancer Center
		Yuhchyau Chen	Ph: 585-396-6161
	Commack
	Memorial Sloan-Kettering Cancer Center
		Nancy Lee, MD	Ph: 212-639-3341
	Cooperstown
	Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
		Timothy Campbell	Ph: 607-547-3336
	New York
	Beth Israel Medical Center - Petrie Division
		Clinical Trials Office - Beth Israel Medical Center - Petrie D	Ph: 212-844-6286
	Rochester
	Highland Hospital of Rochester
		Yuhchyau Chen	Ph: 585-473-2200
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Yuhchyau Chen	Ph: 585-275-5345
	University Radiation Oncology at Parkridge Hospital
		Yuhchyau Chen	Ph: 585-225-3989
	Rockville Centre
	Memorial Sloan-Kettering Cancer Center - Rockville Centre
		Nancy Lee, MD	Ph: 212-639-3341
	Sleepy Hollow
	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
		Nancy Lee, MD	Ph: 212-639-3341
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph: 828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Cente	Ph: 877-668-0683; 919-966-4432
	Kinston
	Kinston Medical Specialists
		Peter R. Watson, MD	Ph: 252-559-2200ext.201
	Raleigh
	Cancer Centers of North Carolina - Raleigh
		Vivek S. Kavadi	Ph: 919-781-7070
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Mitchell L. Fromm, MD	Ph: 330-344-6448
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph: 330-375-6101
	Barberton
	Barberton Citizens Hospital
		William F. Demas, MD	Ph: 330-375-3557
	Canton
	Mercy Cancer Center at Mercy Medical Center
		Edward J. Walsh	Ph: 330-430-2788
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Kevin P. Redmond, MD	Ph: 513-584-9089
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph: 800-641-2422
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fai	Ph: 216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente	Ph: 866-223-8100
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce J. Averbook, MD, FACS	Ph: 216-778-4795
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph: 866-627-7616
			Email: Jamesline@osumc.edu
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		David J. Adelstein	Ph: 440-312-4500
	Mentor
	Lake/University Ireland Cancer Center
		Min Yao	Ph: 440-205-5755
	Middleburg Heights
	Southwest General Health Center
		Min Yao	Ph: 440-816-8000
	Oregon
	St. Charles Mercy Hospital
		Rex B. Mowat	Ph: 419-696-7200
	Ravenna
	Robinson Radiation Oncology
		Mitchell L. Fromm, MD	Ph: 330-344-6448
	Sandusky
	North Coast Cancer Care, Incorporated
		David J. Adelstein	Ph: 419-626-9090
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph: 419-824-1842
	West Chester
	Precision Radiotherapy at University Pointe
		Kevin P. Redmond, MD	Ph: 513-584-9089
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Terence S. Herman	Ph: 405-271-6822
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Matthew C. Solhjem	Ph: 503-513-3300
	Eugene
	Willamette Valley Cancer Center - Eugene
		Vivek S. Kavadi	Ph: 541-683-5001
	Portland
	CCOP - Columbia River Oncology Program
		Matthew C. Solhjem	Ph: 503-216-6260
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Hea	Ph: 503-494-1080
			Email: trials@ohsu.edu
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		Clinical Trials Office - Legacy Good Samaritan Hospital & Com	Ph: 503-413-1742
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providenc	Ph: 503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph: 503-215-6412
	Veterans Affairs Medical Center - Portland
		Neil D. Gross	Ph: 503-220-8262
	Salem
	Salem Hospital Regional Cancer Care Services
		Clinical Trials Office - Salem Hospital Regional Cancer Care S	Ph: 503-561-2618
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Eliot L. Friedman, MD	Ph: 610-402-0512
	East Stroudsburg
	Dale and Frances Hughes Cancer Center at Pocono Medical Center
		Rita S. Axelrod, MD	Ph: 215-955-8874
	Erie
	Regional Cancer Center - Erie
		Andrew T. Figura	Ph: 814-838-9000
	Gettysburg
	Adams Cancer Center
		Amit B. Shah	Ph: 717-741-8180
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphi	Ph: 215-728-4790
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer	Ph: 215-955-6084
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph: 610-988-9323
	York
	York Cancer Center at Apple Hill Medical Center
		Amit B. Shah	Ph: 717-741-8180
South Carolina
	Spartanburg
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph: 800-486-5941
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Michael J. Swartz	Ph: 605-719-2360
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph: 800-811-8480
Texas
	Bedford
	Texas Oncology, PA at Harris Center HEB
		Vivek S. Kavadi	Ph: 817-359-9000
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center a	Ph: 866-460-4673; 214-648-7097
	Denton
	Texas Oncology, PA at Texas Cancer Center - Denton South
		Vivek S. Kavadi	Ph: 940-382-1022
	Fort Worth
	Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
		Vivek S. Kavadi	Ph: 817-820-4820
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the U	Ph: 713-792-3245
	Memorial Hermann - Texas Medical Center
		Vivek S. Kavadi	Ph: 713-242-3500
	San Antonio
	Cancer Care Centers of South Texas - Northeast
		Vivek S. Kavadi	Ph: 210-656-7177
	University of Texas Health Science Center at San Antonio
		Ying Li	Ph: 210-567-4777
	Sherman
	Texas Oncology, PA at Texas Cancer Center - Sherman
		Vivek S. Kavadi	Ph: 903-892-9455
	Sugar Land
	Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
		Vivek S. Kavadi	Ph: 281-277-5200
	Wichita Falls
	Texas Oncology, PA - Wichita Falls
		Vivek S. Kavadi	Ph: 940-767-4364
Utah
	Saint George
	Dixie Regional Medical Center - East Campus
		Clinical Trials Office - Dixie Regional Medical Center - East	Ph: 435-688-4167
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Clinical Trials Office - Huntsman Cancer Institute at Universi	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Utah Cancer Specialists at UCS Cancer Center
		Vilija N. Avizonis	Ph: 801-269-0231
Virginia
	Norfolk
	Sentara Cancer Institute at Sentara Norfolk General Hospital
		Clinical Trials Office - Sentara Cancer Institute at Sentara N	Ph: 757-388-2406
	Richmond
	Veterans Affairs Medical Center - Richmond
		Clinical Trials Office - Veterans Affairs Medical Center - Ric	Ph: 804-675-5646
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Masse	Ph: 804-628-1939
	Virginia Beach
	Coastal Cancer Center at Sentara Virginia Beach General Hospital
		Scott S. Williams	Ph: 757-395-8686
Washington
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph: 509-228-1083
	Tacoma
	CCOP - Northwest
		Yoshio Inoue	Ph: 253-403-1461
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Matthew C. Solhjem	Ph: 360-944-9889
	Southwest Washington Medical Center Cancer Center
		Matthew C. Solhjem	Ph: 360-514-2174
Wisconsin
	Antigo
	Langlade Memorial Hospital
		Darryl R. Barton, MD	Ph: 715-847-2866
	Appleton
	Fox Valley Hematology and Oncology - East Grant Street
		Robert R. Kohl	Ph: 920-749-1171
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbo	Ph: 608-262-5223
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer C	Ph: 414-805-4380
	Veterans Affairs Medical Center - Milwaukee
		Elizabeth M. Gore, MD	Ph: 414-805-4369
Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
		Susan Chafe, MD	Ph: 780-432-8518
Newfoundland and Labrador
	Saint John's
	Doctor H. Bliss Murphy Cancer Centre
		Craig M. Pochini	Ph: 709-777-7589
Nova Scotia
	Halifax
	Nova Scotia Cancer Centre
		Helmut Hollenhorst	Ph: 902-473-6000
Ontario
	London
	London Regional Cancer Program at London Health Sciences Centre
		Nancy E. Read	Ph: 519-685-8615
	Ottawa
	Ottawa Hospital Regional Cancer Centre - General Campus
		Samy El-Sayed	Ph: 613-737-7700 ext. 70209
	Sudbury
	Northeastern Ontario Regional Cancer Centre
		Adam K. Andronowski	Ph: 705-522-6237
	Toronto
	Princess Margaret Hospital
		John (Joon-Hyung) Kim	Ph: 416-946-2811
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Edith J. Filion	Ph: 514-281-6000
	McGill Cancer Centre at McGill University
		George Shenouda	Ph: 514-398-1444
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Evgeny Sadikov	Ph: 306-766-2203
Hong Kong
	Shatin
	Prince of Wales Hospital
		Michael K.M. Kam	Ph: 852-636-3337

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00956007
Information obtained from ClinicalTrials.gov on November 20, 2012

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