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

Trial Status: Closed to Accrual and Intervention

This randomized phase III trial studies radiation therapy alone to see how well it works compared with radiation therapy and cetuximab in treating patients who have undergone surgery for head and neck cancer that has spread to nearby tissues or organs. Radiation therapy uses high-energy x-rays to kill tumor cells. Using a 3-dimensional (3-D) image of the tumor to help focus the radiation directly onto the tumor, and giving the radiation in higher doses over a shorter period of time, may kill more tumor cells and cause fewer side effects. Monoclonal antibodies, such as cetuximab, may block tumor growth by targeting certain cells. 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.

Inclusion Criteria

  • Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS], etc.) of the head/neck (oral cavity, oropharynx or larynx); note: hypopharynx primaries are excluded
  • Clinical stage T1, N1-2 or T2-4a, N0-2, M0 including no distant metastases, based upon the following minimum diagnostic workup: * General history and physical examination by a radiation oncologist and/or medical oncologist within 8 weeks prior to registration * Examination by an ear, nose and throat (ENT) or head & neck surgeon, within 8 weeks prior to registration; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is recommended but not required * Chest x-ray (at a minimum) or chest computed tomography (CT) scan (with or without contrast) or CT/positron emission tomography (PET) of chest (with or without contrast) within 8 weeks prior to registration
  • Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following “intermediate” risk factors: * 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; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient * Pathologically confirmed T3 or T4a primary tumor; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient * T2 oral cavity cancer with > 5 mm depth of invasion
  • Zubrod performance status 0-1
  • Absolute granulocyte count (AGC) >= 1,500/mm³
  • Platelet count >= 100,000/mm³
  • Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Total bilirubin < 2 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN
  • Serum creatinine < 2 x institutional ULN or; creatinine clearance (CC) >= 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
  • The following assessments are required within 2 weeks prior to the start of registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  • Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses

Exclusion Criteria

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago; patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with primary tumor (T)1-2, nearby lymph nodes (N)0, metastasis (M)0 resected differentiated thyroid carcinoma, who are eligible
  • Per the operative and/or pathology report, 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; note: 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; for questions or ambiguities about an individual case, contact Dr. Machtay and/or Dr. Holsinger prior to enrolling the patient
  • Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration * Transmural myocardial infarction within 6 months prior to registration * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients * Grade 3-4 electrolyte abnormalities (CTCAE, v. 4): ** Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels ** Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L) ** Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels ** Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels ** Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to cetuximab

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Sharon A. Spencer
Phone: 205-934-0220

Alaska

Anchorage
Providence Alaska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871

Arizona

Phoenix
Cancer Center at Saint Joseph's
Status: CLOSED_TO_ACCRUAL
Contact: Panayiotis (Panos) Savvides
Phone: 412-339-5294
Tucson
Arizona Oncology Associates-West Orange Grove
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 520-544-2919
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Sun K Yi
Phone: 520-626-9008

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Omar T Atiq
Phone: 501-686-8274

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Shyam S. D. Rao
Phone: 661-323-4673
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Carmichael
Mercy San Juan Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 916-537-5237
Chico
Adventist Health Cancer Care Center Chico
Status: CLOSED_TO_ACCRUAL
Contact: Sam Mazj
Phone: 530-876-7995
Email: haleew@ah.org
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nayana Lalit Vora
Phone: 800-826-4673
Fresno
Fresno Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 877-642-4691
Email: Kpoct@kp.org
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Loren K. Mell
Phone: 858-822-5354
Los Angeles
Cedars Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Zachary Stephan Zumsteg
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael Raymond Girvigian
Phone: 800-398-3996
Los Angeles County-USC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Naomi Rachel Schechter
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Naomi Rachel Schechter
Phone: 323-865-0451
Modesto
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Oakland
Bay Area Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: James Henry Feusner
Phone: 510-465-2242
Kaiser Permanente Oakland-Broadway
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Parima Daroui
Phone: 877-827-8839
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
Contact: Quynh-Thu Xuan Le
Phone: 650-498-7061
Pomona
Pomona Valley Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Yallapragada S. (Ram) Rao
Phone: 909-865-9555
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
The Permanente Medical Group-Roseville Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Mercy General Hospital Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 916-453-4528
Sutter Medical Center Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shyam S. D. Rao
Phone: 916-734-3089
Saint Helena
Saint Helena Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David John Tate
Phone: 707-967-3698
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Sue Sun Yom
Phone: 877-827-3222
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 877-642-4691
Email: Kpoct@kp.org
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Sana Dole Karam
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 308-398-6518
Denver
Porter Adventist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 308-398-6518
Englewood
Swedish Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Greeley
North Colorado Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663

Connecticut

Bridgeport
Hartford HealthCare - Saint Vincent's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Michael Iannuzzi
Phone: 412-339-5294
Hartford
Hartford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Neal B. Goldberg
Phone: 860-545-5363
Middletown
Middlesex Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Susanna Hong
Phone: 860-358-2058
New Britain
The Hospital of Central Connecticut
Status: CLOSED_TO_ACCRUAL
Contact: Neal B. Goldberg
Phone: 860-224-5660
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Zain A. Husain
Phone: 203-785-5702
Norwich
William Backus Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Dennis E. Slater
Phone: 412-339-5294

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Adam Raben
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: CLOSED_TO_ACCRUAL
Contact: Adam Raben
Phone: 302-645-3100
Seaford
TidalHealth Nanticoke / Allen Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Adam Raben
Phone: 302-645-3100

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: CLOSED_TO_ACCRUAL
Contact: Michael A. Samuels
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: CLOSED_TO_ACCRUAL
Contact: Michael A. Samuels
Phone: 305-243-2647
Jacksonville
Baptist MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 412-339-5294
Baptist Medical Center South
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 412-339-5294
Integrated Community Oncology Network-Southside Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 888-823-5923
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Contact: Robert L. Foote
Phone: 855-776-0015
Jacksonville Beach
Integrated Community Oncology Network-Florida Cancer Center Beaches
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 888-823-5923
Miami
Miami Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Andre A. Abitbol
Phone: 800-599-2456
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael A. Samuels
Phone: 305-243-2647
Orange Park
21st Century Oncology-Orange Park
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 888-823-5923
Orlando
AdventHealth Orlando
Status: CLOSED_TO_ACCRUAL
Contact: Lee M. Zehngebot
Phone: 407-303-2090
UF Cancer Center at Orlando Health
Status: CLOSED_TO_ACCRUAL
Contact: Rafael Ricardo Manon
Phone: 321-841-7246
Palatka
Cancer Center of Putnam
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 888-823-5923
Saint Augustine
Integrated Community Oncology Network-Flager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Douglas W. Johnson
Phone: 888-823-5923

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 404-778-1868
Emory University Hospital Midtown
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 888-946-7447
Grady Health System
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Jay Beitler
Phone: 404-489-9164
Decatur
Atlanta VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Scott Edelman
Phone: 404-321-6111ext7632
Gainesville
Northeast Georgia Medical Center-Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: Frank Greer Lake
Phone: 770-219-8800
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: CLOSED_TO_ACCRUAL
Contact: John A. Pablo
Phone: 412-339-5294
Memorial Health University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Aaron Watson Pederson
Phone: 912-350-7887

Hawaii

Honolulu
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Richard Y. Lee
Phone: 412-339-5294
The Cancer Center of Hawaii-Liliha
Status: CLOSED_TO_ACCRUAL
Contact: Richard Y. Lee
Phone: 808-547-6881
University of Hawaii Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Richard Y. Lee
Phone: 808-586-2979

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: CLOSED_TO_ACCRUAL
Contact: Thomas E. Lad
Phone: 312-864-5204
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Bharat B. Mittal
Phone: 312-695-1301
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Lawrence Eric Feldman
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bruce E. Brockstein
Phone: 847-570-2109
Harvey
Ingalls Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Sulochana D. Yalavarthi
Phone: 708-915-4673
Hines
Edward Hines Jr VA Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Cheryl M. Czerlanis
Phone: 708-202-8387
Joliet
Joliet Oncology-Hematology Associates Limited
Status: CLOSED_TO_ACCRUAL
Contact: Jason Jung-Gon Suh
Phone: 815-730-3098
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Bahman Emami
Phone: 708-202-8387
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 309-243-3605
Peoria
Methodist Medical Center of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 309-243-3605
Peru
Valley Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 815-664-4141
Rockford
SwedishAmerican Regional Cancer Center / ACT
Status: CLOSED_TO_ACCRUAL
Contact: Harvey E. Einhorn
Phone: 779-696-9400
Springfield
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-788-3528
Saint John's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samuel P. Au
Phone: 412-339-5294
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kalika Prasad Sarma
Phone: 800-446-5532

Indiana

Bloomington
IU Health Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Fred Y. Wu
Phone: 812-353-2831
Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 260-373-8888
Radiation Oncology Associates PC
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 877-437-2408
Goshen
Goshen Center for Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: James A. Wheeler
Phone: 574-364-2973
Indianapolis
Community Cancer Center East
Status: CLOSED_TO_ACCRUAL
Contact: Shih Jack Wei
Phone: 317-497-2823
Community Cancer Center North
Status: CLOSED_TO_ACCRUAL
Contact: Shih Jack Wei
Phone: 317-497-2823
IU Health Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Alexander M. Yeh
Phone: 765-646-8358
Muncie
IU Health Ball Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Yunjie Xie Lin
Phone: 765-751-5850
South Bend
Memorial Hospital of South Bend
Status: CLOSED_TO_ACCRUAL
Contact: David Alan Hornback
Phone: 800-284-7370

Iowa

Ames
McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Joseph James Merchant
Phone: 515-239-2621
Des Moines
Iowa Methodist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert J. Behrens
Phone: 515-241-6727
Mercy Medical Center - Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 308-398-6518
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark Charles Smith
Phone: 800-237-1225
Sioux City
Siouxland Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Donald B. Wender
Phone: 712-252-0088

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Lominska
Phone: 913-945-7552
Overland Park
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Lominska
Phone: 913-945-7552

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mahesh Ravindra Kudrimoti
Phone: 859-257-3379
Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: CLOSED_TO_ACCRUAL
Contact: Shiao Y. Woo
Phone: 502-562-3429
Owensboro
Owensboro Health Mitchell Memorial Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Ryan Jared Abel
Phone: 270-688-3691

Louisiana

Baton Rouge
Mary Bird Perkins Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 225-215-1353
Metairie
East Jefferson General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-210-3539
New Orleans
Louisiana State University Health Science Center
Status: ACTIVE
Contact: Mitchell Machtay
Phone: 800-641-2422
Touro Infirmary
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-210-3539
Tulane University Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven Joseph DiBiase
Phone: 504-988-6121
University Medical Center New Orleans
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-903-3000

Maine

Lewiston
Central Maine Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Courtney A. Jensen
Phone: 207-795-8250

Maryland

Baltimore
Greater Baltimore Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Marshall A. Levine
Phone: 443-849-3706
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James William Snider
Phone: 800-888-8823
Bel Air
UM Upper Chesapeake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mohan Suntha
Phone: 443-643-3010
Salisbury
TidalHealth Peninsula Regional
Status: CLOSED_TO_ACCRUAL
Contact: John Romeo Mansueti
Phone: 866-922-6237

Massachusetts

Boston
Boston Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Minh Tam Truong
Phone: 617-638-8265
Tufts Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Miriam O'Leary
Phone: 617-636-5000
Burlington
Lahey Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Francis Warren Nugent
Phone: 781-744-8027
Pittsfield
Berkshire Medical Center - Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Harvey Zimbler
Phone: 413-496-8205

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Avraham Eisbruch
Phone: 800-865-1125
Bay City
McLaren Cancer Institute-Bay City
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Dearborn
Beaumont Hospital - Dearborn
Status: CLOSED_TO_ACCRUAL
Contact: Daniel J. Krauss
Phone: 248-551-7695
Detroit
Ascension Saint John Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Eleanor M. Walker
Phone: 313-916-1784
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Harold E. Kim
Phone: 313-576-9790
Flint
McLaren Cancer Institute-Flint
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Kalamazoo
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Livonia
Saint Mary Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Mount Clemens
McLaren Cancer Institute-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Owosso
McLaren Cancer Institute-Owosso
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Pontiac
Saint Joseph Mercy Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Daniel J. Krauss
Phone: 248-551-7695
Saginaw
Ascension Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 412-339-5294
Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Daniel J. Krauss
Phone: 248-551-7695
Warren
Saint John Macomb-Oakland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671

Minnesota

Albert Lea
Mayo Clinic Health System in Albert Lea
Status: CLOSED_TO_ACCRUAL
Contact: Robert L. Foote
Phone: 855-776-0015
Coon Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Duluth
Saint Luke's Hospital of Duluth
Status: CLOSED_TO_ACCRUAL
Contact: Steven R. Bonin
Phone: 412-339-5294
Fridley
Unity Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Mankato
Mayo Clinic Health Systems-Mankato
Status: CLOSED_TO_ACCRUAL
Contact: Robert L. Foote
Phone: 855-776-0015
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Minneapolis
Minneapolis VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Sharon Davis Luikart
Phone: 612-467-2800
Northfield
Mayo Clinic Radiation Therapy-Northfield
Status: CLOSED_TO_ACCRUAL
Contact: Robert L. Foote
Phone: 855-776-0015
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Robert L. Foote
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Madhava Rao Kanakamedala
Phone: 601-815-6700
Pascagoula
Singing River Hospital
Status: CLOSED_TO_ACCRUAL
Contact: James E. Clarkson
Phone: 228-809-5292

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 573-651-5550
Columbia
University of Missouri - Ellis Fischel
Status: CLOSED_TO_ACCRUAL
Contact: Donald C. Doll
Phone: 573-882-7440
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Joplin
Freeman Health System
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 417-347-4030
Kansas City
Kansas City Veterans Affairs Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: John Ho Park
Phone: 800-525-1483
North Kansas City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Lominska
Phone: 816-691-1599
University of Kansas Cancer Center - North
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Lominska
Phone: 913-945-7552
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Lominska
Phone: 412-339-5294
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 314-251-6770
Mercy Hospital South
Status: CLOSED_TO_ACCRUAL
Contact: Minxiang (Michael) Gu
Phone: 888-823-5923
Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 314-996-5569
Saint Louis University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bruce James Walz
Phone: 314-977-4440
Siteman Cancer Center-South County
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wade L. Thorstad
Phone: 800-600-3606
Springfield
CoxHealth South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 417-269-4520
Mercy Hospital Springfield
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 417-269-4520

Montana

Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-996-2663
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 406-969-6060

Nebraska

Lincoln
Saint Elizabeth Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 308-398-6518
Omaha
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Tien-Shew William Huang
Phone: 402-354-5144
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Weining Zhen
Phone: 402-559-6941

Nevada

Reno
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: John Allan Ellerton
Phone: 702-384-0013

New Hampshire

Exeter
Exeter Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gary Miller Proulx
Phone: 800-439-3837
Keene
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 603-354-5454ext2155
Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 800-639-6918

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: CLOSED_TO_ACCRUAL
Contact: Nancy Y. Lee
Phone: 212-639-7592
Camden
Cooper Hospital University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Ashish Bharat Patel
Phone: 856-325-6757
Elizabeth
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Status: CLOSED_TO_ACCRUAL
Contact: Rita S. Axelrod
Phone: 908-994-8000
Mount Holly
Virtua Memorial
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762
New Brunswick
Saint Peter's University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gopal Rao Desai
Phone: 888-823-5923
Newark
Rutgers New Jersey Medical School
Status: CLOSED_TO_ACCRUAL
Contact: Omar Mee Mahmoud
Phone: 732-235-8675
Plainsboro
Penn Medicine Princeton Health
Status: CLOSED_TO_ACCRUAL
Contact: Joseph M. Pepek
Phone: 609-497-4475
Sparta
Sparta Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Rita S. Axelrod
Phone: 973-729-7001
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Ashish Bharat Patel
Phone: 856-325-6757
Virtua Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 856-247-7395

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Benny J. Liem
Phone: 505-925-0366

New York

Albany
New York Oncology Hematology PC - Albany
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 518-489-3612
Brooklyn
Maimonides Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jay Scott Cooper
Phone: 718-765-2500
New York-Presbyterian / Brooklyn Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Krishnamurthi Sundaram
Phone: 718-780-3677
Canandiaqua
Sands Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Yuhchyau Chen
Phone: 585-396-6161
Commack
Memorial Sloan Kettering Commack
Status: CLOSED_TO_ACCRUAL
Contact: Nancy Y. Lee
Phone: 212-639-7592
Cooperstown
Mary Imogene Bassett Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Timothy Campbell
Phone: 888-823-5923
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Chi K. Tsang
Phone: 607-271-7000
Glens Falls
Glens Falls Hospital
Status: CLOSED_TO_ACCRUAL
Contact: John Patrick Stoutenburg
Phone: 518-926-6700
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nancy Y. Lee
Phone: 212-639-7592
Mount Sinai Union Square
Status: CLOSED_TO_ACCRUAL
Contact: Bruce E. Culliney
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
Highland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Yuhchyau Chen
Phone: 585-341-8113
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Yuhchyau Chen
Phone: 585-275-5830
Wilmot Cancer Institute Radiation Oncology at Greece
Status: CLOSED_TO_ACCRUAL
Contact: Yuhchyau Chen
Phone: 585-723-7740
Sleepy Hollow
Memorial Sloan Kettering Sleepy Hollow
Status: CLOSED_TO_ACCRUAL
Contact: Nancy Y. Lee
Phone: 212-639-7202
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Seung Shin Hahn
Phone: 315-464-5476
Uniondale
Memorial Sloan Kettering Nassau
Status: CLOSED_TO_ACCRUAL
Contact: Nancy Y. Lee
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: CLOSED_TO_ACCRUAL
Contact: Nancy Y. Lee
Phone: 212-639-7592

North Carolina

Asheville
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Christopher H. Chay
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Bhishamjit S. Chera
Phone: 877-668-0683
Charlotte
Atrium Health Pineville / LCI-Pineville
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin James Moeller
Phone: 800-804-9376
Atrium Health University City / LCI-University
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin James Moeller
Phone: 800-804-9376
Carolinas Medical Center / Levine Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin James Moeller
Phone: 704-355-2884
Concord
Atrium Health Cabarrus / LCI-Concord
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin James Moeller
Phone: 704-403-1520
Gastonia
CaroMont Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Charles J. Meakin
Phone: 704-834-2810
Goldsboro
Wayne Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: James N. Atkins
Phone: 252-399-7491
Kinston
Vidant Oncology-Kinston
Status: CLOSED_TO_ACCRUAL
Contact: Peter Robins Watson
Phone: 252-559-2200
Monroe
Atrium Health Union / LCI-Union
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin James Moeller
Phone: 980-993-2826
Raleigh
Duke Women's Cancer Care Raleigh
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 412-339-5294
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Kathryn McConnell Greven
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 800-437-4010
Sanford Roger Maris Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 701-234-6161
Grand Forks
Altru Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Grant Richard Seeger
Phone: 701-780-6520
Minot
Trinity Cancer Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael E. Grant
Phone: 800-862-0005

Ohio

Akron
Cleveland Clinic Akron General
Status: CLOSED_TO_ACCRUAL
Contact: Mitchel L. Fromm
Phone: 330-344-6348
Summa Health System - Akron Campus
Status: CLOSED_TO_ACCRUAL
Contact: Desiree E. Doncals
Phone: 330-375-6101
Barberton
Summa Health System - Barberton Campus
Status: CLOSED_TO_ACCRUAL
Contact: Desiree E. Doncals
Phone: 330-615-4132
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 216-844-1374
Canton
Mercy Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Edward J. Walsh
Phone: 888-293-4673
Chardon
Geauga Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 412-339-5294
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Redmond
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 216-476-9362
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 866-223-8100
MetroHealth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Bruce J. Averbook
Phone: 216-778-8526
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Aashish Dipak Kumar Bhatt
Phone: 800-293-5066
Elyria
Mercy Cancer Center-Elyria
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 440-324-0400
Independence
Cleveland Clinic Cancer Center Independence
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 800-544-6333
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 412-339-5294
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 440-312-4293
Medina
Summa Health Medina Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Desiree E. Doncals
Phone: 330-375-4045
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 440-205-5491
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 440-816-5050
Oregon
Saint Charles Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rex B. Mowat
Phone: 517-265-0116
Parma
University Hospitals Parma Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 440-743-4747
Portsmouth
Southern Ohio Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2118
Ravenna
University Hospitals Portage Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mitchel L. Fromm
Phone: 412-339-5294
Sandusky
North Coast Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 412-339-5294
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 412-339-5294
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 412-339-5294
Sylvania
ProMedica Flower Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Abhijit B. Saste
Phone: 419-824-1842
Toledo
Mercy Saint Anne Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rex B. Mowat
Phone: 419-407-1160
West Chester
University Pointe
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Redmond
Westlake
UHHS-Westlake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Min Yao
Phone: 216-844-1374
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: CLOSED_TO_ACCRUAL
Contact: David J. Adelstein
Phone: 800-862-7798

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Terence S. Herman
Phone: 405-271-8777

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614
Eugene
Willamette Valley Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 541-681-4930
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Y. Kee
Phone: 855-776-0015
Oregon Health and Science University
Status: CLOSED_TO_ACCRUAL
Contact: Daniel Robert Clayburgh
Phone: 503-494-1080
Portland VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Daniel Robert Clayburgh
Phone: 800-949-1004
Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614
Salem
Salem Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Matthew S. Gordon
Phone: 888-823-5923

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: CLOSED_TO_ACCRUAL
Contact: Samir Narayan
Phone: 734-712-3671
Beaver
UPMC-Heritage Valley Health System Beaver
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 724-773-7616
Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael J. Greenberg
Phone: 570-271-5251
Dunmore
Northeast Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Rita S. Axelrod
Phone: 888-808-6762
East Stroudsburg
Pocono Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rita S. Axelrod
Phone: 570-422-1700
Easton
Easton Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rajen P. Oza
Phone: 610-250-4000
Erie
UPMC Hillman Cancer Center Erie
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Thomas Figura
Phone: 412-621-2334
Gettysburg
Adams Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Amit B. Shah
Phone: 877-441-7957
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 724-838-1900
Hanover
Cherry Tree Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Amit B. Shah
Phone: 877-441-7957
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: CLOSED_TO_ACCRUAL
Contact: David C. Weksberg
Phone: 717-724-6765
Johnstown
UPMC-Johnstown / John P. Murtha Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 814-534-4724
Langhorne
Saint Mary Medical and Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert E. Reilly
Phone: 215-710-4585
McKeesport
UPMC Cancer Center at UPMC McKeesport
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-647-8073
Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-604-2020
Philadelphia
Einstein Medical Center Philadelphia
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth Lee Zeitzer
Phone: 215-456-3880
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Thomas James Galloway
Phone: 215-728-4790
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rita S. Axelrod
Phone: 215-955-6084
University of Pennsylvania / Abramson Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Alexander Lin
Phone: 412-647-8073
Pittsburgh
UPMC Jefferson Regional Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-469-5500
UPMC-Passavant Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-502-3920
UPMC-Saint Margaret
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-784-4900
UPMC-Shadyside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 412-621-2334
Pottstown
Pottstown Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wei Song
Phone: 610-327-7544
Seneca
UPMC Cancer Center at UPMC Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 814-676-7900
Washington
UPMC Washington Hospital Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Dwight Earl Heron
Phone: 724-223-3788
West Reading
Reading Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Michael L. Haas
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael J. Greenberg
Phone: 570-271-5251
York
WellSpan Health-York Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Amit B. Shah
Phone: 877-441-7957

South Carolina

Anderson
AnMed Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Leander Cannick
Phone: 864-512-4651
Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Anand Kumar Sharma
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Saint Francis Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeremy M. Kilburn
Phone: 864-603-6213
Greer
Gibbs Cancer Center-Pelham
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 864-560-6104
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Rock Hill
Rock Hill Radiation Therapy Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin James Moeller
Phone: 412-339-5294
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 864-560-6104

South Dakota

Rapid City
Rapid City Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Michael J. Swartz
Phone: 605-716-3982
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 605-312-3320

Tennessee

Kingsport
Wellmont Holston Valley Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Asheesh Shipstone
Phone: 423-578-8538
Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Anthony J. Cmelak
Phone: 800-811-8480

Texas

Abilene
Texas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 412-339-5294
Austin
Texas Oncology - Central Austin Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 512-427-9400
Texas Oncology - South Austin Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 512-447-2202
Texas Oncology-Austin Midtown
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 512-421-4163
Bedford
Texas Oncology Bedford
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 817-359-9000
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: David Jonathan Sher
Phone: 214-648-7097
Denton
Texas Oncology-Denton South
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 940-382-1022
Flower Mound
Texas Oncology-Flower Mound
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 972-537-4100
Fort Worth
Texas Oncology - Fort Worth Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 817-820-4700
Houston
Ben Taub General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jun Zhang
Phone: 713-873-2000
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Erich Madison Sturgis
Phone: 877-312-3961
Memorial Hermann Memorial City Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 412-339-5294
Michael E DeBakey VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Weiyuan Michael Mai
Phone: 800-553-2278
Plano
Texas Oncology-Plano West
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 412-339-5294
Round Rock
Texas Oncology - Round Rock Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 512-341-8724
Texas Oncology-Seton Williamson
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 512-687-2300
San Antonio
Cancer Care Centers of South Texas- Northeast
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 210-656-7177
University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Ying Li
Phone: 210-450-3800
Sherman
Texas Cancer Center-Sherman
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 903-868-4700
Sugar Land
Texas Oncology Cancer Center Sugar Land
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 281-277-5200
Webster
Deke Slayton Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 412-339-5294
Wichita Falls
Texas Oncology-Wichita Falls Texoma Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 940-691-8271

Utah

Murray
Intermountain Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-507-3950
Provo
Utah Valley Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-357-7965
Saint George
Dixie Medical Center Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 435-688-4167
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Ying Jia Hitchcock
Phone: 888-424-2100
LDS Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: CLOSED_TO_ACCRUAL
Contact: Vilija N. Avizonis
Phone: 801-933-6070

Vermont

Saint Johnsbury
Norris Cotton Cancer Center-North
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 802-473-4100

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Read
Phone: 434-243-6322
Hampton
Sentara Cancer Institute at Sentara CarePlex Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Scott S. Williams
Phone: 412-339-5294
Norfolk
Sentara Norfolk General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Scott S. Williams
Phone: 757-388-2406
Richmond
Hunter Holmes McGuire Veterans Administration Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Drew Moghanaki
Phone: 804-675-5646
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Harry Douglas Bear
Phone: 412-339-5294
Virginia Beach
Sentara Virginia Beach General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Scott S. Williams
Phone: 412-339-5294

Washington

Bremerton
Harrison Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 308-398-6518
Kennewick
Tri-Cities Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: George E. Laramore
Phone: 800-377-0856
Mount Vernon
Skagit Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: George E. Laramore
Phone: 360-814-2687
Seattle
University of Washington Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: George E. Laramore
Phone: 206-616-8289
Spokane
Cancer Care Northwest - Spokane South
Status: CLOSED_TO_ACCRUAL
Contact: George E. Laramore
Phone: 509-228-1083
Cancer Care Northwest-North Spokane
Status: CLOSED_TO_ACCRUAL
Contact: George E. Laramore
Phone: 509-228-1083
Tacoma
Northwest NCI Community Oncology Research Program
Status: ADMINISTRATIVELY_COMPLETE
Contact: Yoshio Inoue
Phone: 800-351-7955
Vancouver
Compass Oncology Vancouver
Status: CLOSED_TO_ACCRUAL
Contact: Vivek S. Kavadi
Phone: 360-449-6521
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin Buckner Bridges
Phone: 360-514-3940
Wenatchee
Wenatchee Valley Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: George E. Laramore
Phone: 509-665-5800

West Virginia

Morgantown
West Virginia University Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Mohammed Almubarak
Phone: 304-293-7374
Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jondavid Pollock
Phone: 304-243-6442

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Darryl Roderick Barton
Phone: 715-623-9869
Appleton
ThedaCare Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert R. Kohl
Phone: 920-433-8889
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 412-339-5294
Johnson Creek
UW Cancer Center Johnson Creek
Status: CLOSED_TO_ACCRUAL
Contact: Paul Maurice Harari
Phone: 920-699-3500
La Crosse
Gundersen Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Collin D. Driscoll
Phone: 608-775-2385
Mayo Clinic Health System-Franciscan Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Robert L. Foote
Phone: 855-776-0015
Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Paul Maurice Harari
Phone: 800-622-8922
Marinette
Bay Area Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 920-433-8889
Milwaukee
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Christopher J. Schultz
Phone: 414-805-4380
Zablocki Veterans Administration Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 888-469-6614
Sheboygan
HSHS Saint Nicholas Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 920-433-8889
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: CLOSED_TO_ACCRUAL
Contact: Eva N. Christensen
Phone: 920-433-8889
Wausau
Aspirus Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Darryl Roderick Barton
Phone: 877-405-6866
Wisconsin Rapids
Aspirus UW Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul Maurice Harari
Phone: 715-422-7718

Alberta

Edmonton
Cross Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Rufus Arni Scrimger
Phone: 780-432-8500

Manitoba

Winnipeg
CancerCare Manitoba
Status: CLOSED_TO_ACCRUAL
Contact: James Blake Butler
Phone: 866-561-1026

Newfoundland

St. John's
Doctor H. Bliss Murphy Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Craig Michael Pochini
Phone: 709-777-7589

Nova Scotia

Halifax
QEII Health Sciences Centre / Nova Scotia Health Authority
Status: CLOSED_TO_ACCRUAL
Contact: Helmut Hollenhorst
Phone: 902-473-6000

Ontario

London
London Regional Cancer Program
Status: CLOSED_TO_ACCRUAL
Contact: Nancy E. Read
Phone: 519-685-8600
Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: CLOSED_TO_ACCRUAL
Contact: Dany El-Sayah
Phone: 613-761-4395
Ottawa Hospital-Civic Campus
Status: CLOSED_TO_ACCRUAL
Contact: Samy El-Sayed
Phone: 613-761-4395
Sudbury
Health Sciences North
Status: CLOSED_TO_ACCRUAL
Contact: Andrew Pearce
Phone: 706-522-6237ext2401
Toronto
University Health Network-Princess Margaret Hospital
Status: CLOSED_TO_ACCRUAL
Contact: John (Joon-Hyung) Kim
Phone: 416-946-4501

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: CLOSED_TO_ACCRUAL
Contact: Edith J. Filion
Phone: 412-339-5294
CHUM - Hopital Notre-Dame
Status: ACTIVE
Contact: Edith J. Filion
Phone: 514-890-8000ext23611
McGill University Department of Oncology
Status: ACTIVE
Contact: George Shenouda
Phone: 514-934-1934ext42953
The Research Institute of the McGill University Health Centre (MUHC)
Status: CLOSED_TO_ACCRUAL
Contact: George Shenouda
Phone: 514-934-1934ext48354
Quebec City
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Status: CLOSED_TO_ACCRUAL
Contact: Andre Fortin
Phone: 418-649-5593
Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Status: CLOSED_TO_ACCRUAL
Contact: Chang Shu Wang
Phone: 819-820-6480

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Evgeny Sadikov
Phone: 306-766-2213

China

Shatin
Chinese University of Hong Kong-Prince of Wales Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Darren Ming Chun Poon

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: CLOSED_TO_ACCRUAL
Contact: Nasser Al-Rajhi
Phone: 011-966-1-464-7272 ext 38005

PRIMARY OBJECTIVES:

I. Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery.

SECONDARY OBJECTIVES:

I. Assess the impact of the addition of cetuximab to postoperative radiation therapy on disease-free survival (DFS).

II. Assess the impact of the addition of cetuximab to postoperative radiation therapy on acute dysphagia, dry mouth, skin toxicity, and other toxicities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) and their relationships to patient-reported outcomes at 3 months.

III. Assess the impact of the addition of cetuximab to postoperative radiation therapy on late dysphagia, dry mouth, skin toxicity, and other toxicities (CTCAE, v. 4) and their relationships to patient-reported outcomes at 12 and 24 months.

IV. Tumor analysis of epidermal growth factor receptor (EGFR), specifically extent of EGFR overexpression by immunohistochemical (IHC) and fluorescence in situ hybridization (FISH) analysis, EGFR variant III (EGFRvIII) expression, as well as association of these assay data with OS and DFS.

V. Tumor analysis of 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 in this patient subset.

VI. Tumor deoxyribonucleic acid (DNA) analyses of tumor protein 53 (TP53) mutations for response prediction to cetuximab and prognosis.

VII. Germline DNA analyses of polymorphic variants in EGFR intron repeats for response prediction to cetuximab.

TERTIARY OBJECTIVES:

I. Assess the impact of the addition of cetuximab to postoperative radiation therapy on local-regional control.

II. Assess the impact of the addition of cetuximab to postoperative radiation therapy on patient-reported quality of life (QOL), 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).

III. Assess the impact of the addition of cetuximab to postoperative radiation therapy on cost-utility analysis using the EuroQol (EQ-5D).

IV. To evaluate the utility of image-guided radiotherapy (IGRT) as a means of enhancing the efficacy (i.e., local-regional control) of intensity-modulated radiation therapy (IMRT) while reducing the acute and/or late toxicity (particularly xerostomia) and improving patient-reported outcomes (particularly XeQOLS scores).

V. To retrospectively compare the local regional control rate for patients treated with IMRT alone (no IGRT or cetuximab) with similar patients treated with external beam radiotherapy alone in the postoperative trial Radiation Therapy Oncology Group (RTOG) 95-01.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo IMRT once daily (QD) for a total of 30 fractions in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo IMRT as in arm I. Patients also receive cetuximab intravenously (IV) over 60-120 minutes once weekly beginning at least 5 days prior to the start of IMRT for 11 weeks in the absence of disease progression or unacceptable toxicity.

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Mitchell Machtay

  • Primary ID RTOG-0920
  • Secondary IDs NCI-2011-00878, CDR0000651536, NCT01311063
  • Clinicaltrials.gov ID NCT00956007