Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Tissue collection/Repository, TreatmentActive18 and overNCINCI-2011-02601
CDR0000683717, RTOG 1010, U10CA180868, U10CA021661, NCT01196390

Trial Description

Summary

This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may block tumor growth by targeting certain tumor cells and causing them to die. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Further Study Information

PRIMARY OBJECTIVES:

l. To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with human epidermal growth factor receptor 2 (HER2)-overexpressing esophageal adenocarcinoma.

SECONDARY OBJECTIVES:

I. To evaluate if the addition of trastuzumab to trimodality treatment increases the pathologic complete response rate and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma.

II. To develop a tissue bank of tumor tissue from patients with non-metastatic esophageal adenocarcinoma.

III. To determine molecular correlates of complete pathologic response, disease-free survival, and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma treated with neoadjuvant and maintenance trastuzumab.

IV. To evaluate predictors of cardiotoxicity in patients with esophageal cancer treated with trastuzumab and chemoradiation.

V. To evaluate adverse events associated with the addition of trastuzumab to trimodality treatment for patients with non-metastatic esophageal adenocarcinoma.

TERTIARY OBJECTIVES:

I. To determine if the addition of trastuzumab to trimodality treatment improves the patient-reported Functional Assessment of Cancer Therapy for Esophageal Cancer (FACT-E) Esophageal Cancer Subscale (ECS) score.

II. To determine if an improvement in the FACT-E ECS score at 6-8 weeks post completion of neoadjuvant chemoradiation correlates with pathologic complete response.

III. To determine if pathologic complete response correlates with the FACT-E ECS score at 1 year and/or 2 years from the start of chemoradiation.

IV. To determine if the addition of trastuzumab to trimodality treatment improves the Swallow Index and Eating Index Subscale scores of the FACT-E.

V. To determine if the addition of trastuzumab to paclitaxel, carboplatin, and radiation impacts quality-adjusted survival.

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

ARM I: Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel intravenously (IV) over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57. Beginning 21-56 days after surgery, patients receive trastuzumab IV over 30-90 minutes. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

Within 5-8 weeks after completion of radiotherapy, all patients undergo surgery.

After completion of study therapy, patients are followed up every 4 months for 2 years and then yearly thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction; the cancer may involve the stomach up to 5 cm
  • Endoscopy with biopsy
  • PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION
  • Intent to submit tissue for central HER2 testing
  • Stage T1N1-2, T2-3N0-2, according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based on the following minimum diagnostic work-up:
  • Chest/abdominal/pelvic computed tomography (CT) or whole-body positron emission tomography (PET)/CT (NOTE: if CT is performed at this time point, whole-body PET/CT will be required prior to step 2 registration; PET/CT of skull base to mid-thigh is acceptable) (NOTE: if adenopathy is noted on CT or whole-body PET/CT scan, an endoscopic ultrasound is not required prior to STEP 2 registration as long as adequate tissue has been obtained for central HER2 testing)
  • Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be =< 2 cm
  • Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula
  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm³
  • Platelets >=100,000 cells/mm³
  • Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
  • Creatinine =< 2 times upper limit of normal
  • Bilirubin =< 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) =< 3.0 times upper limit of normal
  • For women of childbearing potential, a negative serum or urine pregnancy test
  • Patients must sign a study-specific informed consent prior to study entry
  • CONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)
  • HER2 expressing adenocarcinoma of the esophagus centrally
  • Surgical consultation to confirm that patient will be able to undergo curative resection after completion of chemoradiation within 56 days prior to step 2 registration
  • Radiation oncology consultation to confirm that disease can be encompassed in a radiotherapy field within 56 days prior to step 2 registration
  • Consultation with a medical oncologist within 56 days prior to step 2 registration
  • Stage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the following minimum diagnostic work-up:
  • History/physical examination, with documentation of the patient's weight, within 14 days prior to step 2 registration
  • Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT performed prior to step 1 registration)
  • Endoscopic ultrasound within 56 days prior to step 2 registration, unless the patient is found to have adenopathy per CT or whole-body PET/CT scan
  • Electrocardiogram (EKG) within 56 days prior to step 2 registration
  • Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2 registration
  • Zubrod performance status 0-2 within 14 days prior to step 2 registration
  • For women of childbearing potential, a negative serum pregnancy test within 14 days prior to step 2 registration
  • Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by cardiac echocardiogram (echo) or multi gated acquisition (MUGA) scan within 56 days prior to step 2 registration
  • Women of childbearing potential and sexually active male participants must agree to practice adequate contraception while on study and for at least 60 days following the last dose of chemotherapy or trastuzumab

Exclusion Criteria:

  • Patients with cervical esophageal carcinoma
  • Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)
  • Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiation therapy for esophageal cancer or prior chest radiotherapy
  • Prior anthracycline or taxane
  • Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
  • Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are permissible)
  • Medical contraindications to esophagectomy
  • Prior therapy with any agent targeting the HER2 pathway or human epidermal growth factor receptor 1 (HER1) (epidermal growth factor receptor [EGFR]) pathway
  • Prior therapy with trastuzumab
  • Prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody
  • Previous history of congestive heart failure
  • Severe, active comorbidity, defined as follows:
  • Unstable angina in the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immunocompromised patients
  • Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Howard Safran, Principal Investigator

    Trial Sites

    U.S.A.

    California
    Burlingame

    Peninsula Medical Center

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

    Chico

    Enloe Cancer Center at Enloe Medical Center

    Grace E Yuh
    Ph: 530-332-3808

    Duarte

    City of Hope Comprehensive Cancer Center

    Joseph Chao
    Ph: 800-826-4673
    Email: becomingapatient@coh.org

    Fresno

    Fresno Cancer Center

    Samantha A Seaward
    Ph: 626-564-3455

    Greenbrae

    Marin Cancer Institute at Marin General Hospital

    Lloyd T Miyawaki
    Ph: 415-925-7325

    Los Angeles

    Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Richard Tuli
    Ph: 310-423-8965

    USC/Norris Comprehensive Cancer Center and Hospital

    Heinz-Josef Lenz
    Ph: 323-865-0451

    Heinz-Josef Lenz
    Ph: 323-865-0451

    Modesto

    Memorial Medical Center

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

    Oakland

    Kaiser Permanente-Oakland

    Samantha A Seaward
    Ph: 626-564-3455

    Orange

    Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Chaitali S Nangia
    Ph: 877-827-8839
    Email: ucstudy@uci.edu

    Palo Alto

    Stanford Cancer Center

    Daniel T Chang
    Ph: 650-498-7061
    Email: ccto-office@stanford.edu

    Rancho Cardova

    Kaiser Permanente Medical Center - Rancho Cordova

    Samantha A Seaward
    Ph: 626-564-3455

    Rohnert Park

    Rohnert Park Cancer Center

    Samantha A Seaward
    Ph: 626-564-3455

    Roseville

    Radiation Oncology Center - Roseville

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

    The Permanente Medical Group-Roseville Radiation Oncology

    Samantha A Seaward
    Ph: 626-564-3455

    Sacramento

    South Sacramento Cancer Center

    Samantha A Seaward
    Ph: 626-564-3455

    Sutter Cancer Center

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

    Saint Helena

    Saint Helena Hospital

    David J Tate
    Ph: 707-967-3698

    Santa Clara

    Kaiser Permanente Medical Center - Santa Clara Homestead Campus

    Samantha A Seaward
    Ph: 626-564-3455

    Louis Fehrenbacher
    Ph: 626-564-3455

    South San Francisco

    Kaiser Permanente Cancer Treatment Center

    Samantha A Seaward
    Ph: 626-564-3455

    Vallejo

    Sutter Solano Medical Center

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

    Colorado
    Aurora

    Rocky Mountain Cancer Centers - Aurora

    Eduardo R. Pajon
    Ph: 888-336-8262

    Boulder

    Rocky Mountain Cancer Centers-Boulder

    Keren Sturtz
    Ph: 888-785-6789

    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

    Fort Collins

    Poudre Valley Hospital

    Joshua H Petit
    Ph: 970-482-3328

    Greeley

    North Colorado Medical Center

    Keren Sturtz
    Ph: 888-785-6789

    Longmont

    Hope Cancer Care Center at Longmont United Hospital

    Keren Sturtz
    Ph: 888-785-6789

    Loveland

    McKee Medical Center

    Keren Sturtz
    Ph: 888-785-6789

    Thornton

    Rocky Mountain Cancer Centers - Thornton

    Eduardo R. Pajon
    Ph: 888-336-8262

    Wheat Ridge

    Exempla Lutheran Medical Center

    Keren Sturtz
    Ph: 888-785-6789

    Connecticut
    Hartford

    Helen and Harry Gray Cancer Center at Hartford Hospital

    Andrew L Salner
    Ph: 860-545-5363

    Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Samir Narayan
    Ph: 734-712-4673

    Meriden

    MidState Medical Center

    Andrew L Salner
    Ph: 860-545-5363

    Middletown

    Middlesex Hospital Cancer Center

    Susanna Hong
    Ph: 860-358-2058

    New Haven

    Yale Cancer Center

    Kimberly L Johung
    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

    Adam Raben
    Ph: 302-733-6227

    Florida
    Stuart

    Robert and Carol Weissman Cancer Center at Martin Memorial

    Guillermo Abesada-Terk
    Ph: 772-288-5858ext4

    Georgia
    Atlanta

    Piedmont Hospital

    Adam W Nowlan
    Ph: 404-425-7943
    Email: ORS@piedmont.org

    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

    Idaho
    Boise

    Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Samir Narayan
    Ph: 734-712-4673

    Illinois
    Arlington Heights

    Northwest Community Hospital

    Stephen S. Nigh
    Ph: 847-618-4968

    Chicago

    Louis A. Weiss Memorial Hospital

    Keith L. Shulman
    Ph: 773-564-5044

    University of Illinois Cancer Center

    Neeta K Venepalli
    Ph: 312-355-3046

    Decatur

    Decatur Memorial Hospital Cancer Care Institute

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

    Effingham

    Crossroads Cancer Center

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

    Harvey

    Ingalls Cancer Care Center at Ingalls Memorial Hospital

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

    Rockford

    Advanced Care and Treatment Medical Group, PC

    Harvey Eric Einhorn
    Ph: 779-696-9400
    Email: cancercare@swedishamerican.org

    Springfield

    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

    St. Francis Hospital Cancer Care Services

    Stephen E Rubenstein
    Ph: 317-851-2555

    Mishawaka

    Michiana Hematology-Oncology, PC - Mishawaka

    David A. Hornback
    Ph: 800-284-7370

    Muncie

    Cancer Center at Ball Memorial Hospital

    Yunjie X Lin
    Ph: 765-751-5850

    South Bend

    Memorial Hospital of South Bend

    David A. Hornback
    Ph: 800-284-7370

    Iowa
    Ames

    McFarland Clinic, PC

    Joseph James Merchant
    Ph: 515-239-2621

    Clive

    Mercy Cancer Center - West Lakes

    Mehmet S. Copur
    Ph: 800-998-2119

    Des Moines

    John Stoddard Cancer Center at Iowa Methodist Medical Center

    Robert J Behrens
    Ph: 515-282-2921

    Mercy Cancer Center at Mercy Medical Center - Des Moines

    Mehmet S. Copur
    Ph: 800-998-2119

    Iowa City

    Holden Comprehensive Cancer Center at University of Iowa

    Mark C Smith
    Ph: 800-237-1225

    Sioux City

    Siouxland Hematology-Oncology Associates, LLP

    Donald Bruce Wender
    Ph: 712-252-0088

    Kansas
    Kansas City

    Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Parvesh Kumar
    Ph: 913-588-4709

    Overland Park

    Kansas City Cancer Centers - Southwest

    Parvesh Kumar
    Ph: 913-588-4709

    Salina

    Tammy Walker Cancer Center at Salina Regional Health Center

    Parvesh Kumar
    Ph: 913-588-4709

    Louisiana
    New Orleans

    Ochsner Cancer Institute at Ochsner Clinic Foundation

    Jyotsna Fuloria
    Ph: 888-562-4763

    Maine
    Scarborough

    Maine Medical Center- Scarborough Campus

    Ian J Bristol
    Ph: 207-396-8090
    Email: wrighd@mmc.org

    Maryland
    Baltimore

    Greater Baltimore Medical Center Cancer Center

    Marshall A. Levine
    Ph: 443-849-3706

    Greenebaum Cancer Center at University of Maryland Medical Center

    Mohan Suntharalingam
    Ph: 800-888-8823

    Salisbury

    Peninsula Regional Medical Center

    John R Mansueti
    Ph: 866-922-6237

    Massachusetts
    Boston

    Boston University Cancer Research Center

    Lisa A. Kachnic
    Ph: 617-638-8265

    Massachusetts General Hospital

    Theodore S Hong
    Ph: 877-726-5130

    Burlington

    Lahey Clinic Medical Center - Burlington

    Asa J. Nixon
    Ph: 781-744-8027

    Pittsfield

    Berkshire Hematology Oncology, PC

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

    South Weymouth

    Dana-Farber/Brigham and Women's Cancer Center at South Shore

    Theodore S Hong
    Ph: 877-726-5130

    Springfield

    Baystate Medical Center

    Seth A Kaufman
    Ph: 413-794-9338

    Michigan
    Ann Arbor

    Saint Joseph Mercy Cancer Center

    Samir Narayan
    Ph: 734-712-4673

    University of Michigan Comprehensive Cancer Center

    Howard Safran
    Ph: 401-793-2224
    Email: hsafran@lifespan.org

    Detroit

    Josephine Ford Cancer Center at Henry Ford Hospital

    Eleanor M. Walker
    Ph: 313-916-1784

    Van Elslander Cancer Center at St. John Hospital and Medical Center

    Samir Narayan
    Ph: 734-712-4673

    Flint

    Genesys Hurley Cancer Institute

    Samir Narayan
    Ph: 734-712-4673

    Kalamazoo

    West Michigan Cancer Center

    Sunil Nagpal
    Ph: 269-373-7458

    Livonia

    St. Mary Mercy Hospital

    Samir Narayan
    Ph: 734-712-4673

    Pontiac

    St. Joseph Mercy Oakland

    Samir Narayan
    Ph: 734-712-4673

    Southfield

    Providence Hospital - Southfield

    Michael J. Kraut
    Ph: 248-849-5337
    Email: jaswinder.grewal@stjohn.org

    Warren

    St. John Macomb Hospital

    Samir Narayan
    Ph: 734-712-4673

    Minnesota
    Edina

    Fairview Southdale Hospital

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

    Fridley

    Mercy and Unity Cancer Center at Unity Hospital

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

    Maplewood

    Minnesota Oncology - Maplewood

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

    Minneapolis

    Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

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

    Robbinsdale

    Humphrey Cancer Center at North Memorial Outpatient Center

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

    Rochester

    Mayo Clinic Cancer Center

    Michael G. Haddock
    Ph: 507-538-7623

    Saint Cloud

    CentraCare Clinic - Women and Children

    Barbi L. Kaplan-Frenkel
    Ph: 877-229-4907
    Email: coborncancercenter@centracare.com

    Saint Paul

    Regions Hospital Cancer Care Center

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

    Mississippi
    Jackson

    University of Mississippi Cancer Clinic

    Pierre E De Delva
    Ph: 601-815-6700

    Pascagoula

    Regional Cancer Center at Singing River Hospital

    James E. Clarkson
    Ph: 228-809-5292

    Missouri
    Chesterfield

    Saint Luke's Hospital

    Donald F. Busiek
    Ph: 314-205-6936

    Kansas City

    Kansas City Cancer Centers - North

    Parvesh Kumar
    Ph: 913-588-4709

    Kansas City Cancer Centers - South

    Parvesh Kumar
    Ph: 913-588-4709

    North Kansas City Hospital

    Parvesh Kumar
    Ph: 913-588-4709

    Lee's Summit

    Kansas City Cancer Centers - East

    Parvesh Kumar
    Ph: 913-588-4709

    Rolla

    Phelps County Regional Medical Center

    Jay W Carlson
    Ph: 800-821-7532

    Saint Louis

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

    Jay W Carlson
    Ph: 800-821-7532

    Missouri Baptist Cancer Center

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

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Clifford G Robinson
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    Springfield

    Hulston Cancer Center at Cox Medical Center South

    Jay W Carlson
    Ph: 800-821-7532

    St. John's Regional Health Center

    Jay W Carlson
    Ph: 800-821-7532

    Montana
    Billings

    Billings Clinic Cancer Center - 801 N 29th Street

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Bozeman

    Bozeman Deaconess Cancer Center

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Nebraska
    Grand Island

    Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Mehmet S. Copur
    Ph: 800-998-2119

    Kearney

    Good Samaritan Cancer Center at Good Samaritan Hospital

    Mehmet S. Copur
    Ph: 800-998-2119

    Omaha

    Methodist Estabrook Cancer Center

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

    Nevada
    Henderson

    Comprehensive Cancer Centers of Nevada - Henderson

    John Allan Ellerton
    Ph: 702-384-0013

    Las Vegas

    Cancer Institute of Nevada at Summerlin Hospital Medical Center

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Central Valley

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Northwest

    John Allan Ellerton
    Ph: 702-384-0013

    Comprehensive Cancer Centers of Nevada - Southwest

    John Allan Ellerton
    Ph: 702-384-0013

    Radiation Oncology Centers of Las Vegas - Downtown Location

    John Allan Ellerton
    Ph: 702-384-0013

    Reno

    Renown Institute for Cancer at Renown Regional Medical Center

    Michael C Hardacre
    Ph: 775-982-4400

    New Hampshire
    Concord

    Payson Center for Cancer Care at Concord Hospital

    Su K Metcalfe
    Ph: 800-441-1138

    Dover

    Seacoast Cancer Center at Wentworth - Douglass Hospital

    Taylor M Ortiz
    Ph: 603-740-2150

    Lebanon

    Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Bassem I Zaki
    Ph: 800-639-6918
    Email: cancer.research.nurse@dartmouth.edu

    New Jersey
    Camden

    Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Sucha O Asbell
    Ph: 856-325-6757

    Morristown

    Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Mona Karim
    Ph: 973-971-5900

    Mount Holly

    Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County

    Lemuel S. Ariaratnam
    Ph: 888-847-8823

    Newark

    UMDNJ University Hospital

    Sabin B Motwani
    Ph: 732-235-8675

    Pennington

    Capital Health Medical Center-Hopewell

    Shirnett Karean Williamson
    Ph: 800-255-3440

    Sparta

    Frederick R. and Betty M. Smith Cancer Treatment Center

    Voichita Bar Ad
    Ph: 215-955-6084

    Voorhees

    Cancer Institute of New Jersey at Cooper - Voorhees

    Sucha O Asbell
    Ph: 856-325-6757

    New Mexico
    Albuquerque

    University of New Mexico Cancer Center

    Howard Safran
    Ph: 401-793-2224
    Email: hsafran@lifespan.org

    New York
    Bronx

    Montefiore Medical Center

    Lakshmi Rajdev
    Ph: 718-904-2730
    Email: aecc@aecom.yu.edu

    New York

    Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    Naiyer A Rizvi
    Ph: 212-305-8615

    Rochester

    Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester

    Yuhchyau Chen
    Ph: 585-275-5830

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Yuhchyau Chen
    Ph: 585-275-5830

    North Carolina
    Charlotte

    Blumenthal Cancer Center at Carolinas Medical Center

    Jonathan C Salo
    Ph: 704-355-2884

    Presbyterian Cancer Center at Presbyterian Hospital

    Justin P Favaro
    Ph: 704-384-5369

    Concord

    Batte Cancer Center at Northeast Medical Center

    Jonathan C Salo
    Ph: 704-355-2884

    Kinston

    Kinston Medical Specialists

    Peter R. Watson
    Ph: 252-559-2200

    Monroe

    Edwards Cancer Center at Union Regional Medical Center

    Jonathan C Salo
    Ph: 704-355-2884

    Raleigh

    Rex Cancer Center at Rex Hospital

    Oludamilola A Olajide
    Ph: 919-784-7209

    Winston-Salem

    Wake Forest University Comprehensive Cancer Center

    Maria Matsangou
    Ph: 336-713-6771

    North Dakota
    Minot

    Trinity CancerCare Center

    Kevin Basil Collins
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Ohio
    Akron

    Summa Center for Cancer Care at Akron City Hospital

    Charles A Kunos
    Ph: 330-375-6101

    Barberton

    Barberton Citizens Hospital

    Charles A Kunos
    Ph: 330-375-6101

    Beachwood

    UHHS Chagrin Highlands Medical Center

    Jennifer A Dorth
    Ph: 800-641-2422

    Chardon

    Geauga Regional Hospital

    Jennifer A Dorth
    Ph: 800-641-2422

    Cleveland

    Case Comprehensive Cancer Center

    Jennifer A Dorth
    Ph: 800-641-2422

    MetroHealth Cancer Care Center at MetroHealth Medical Center

    Bruce J. Averbook
    Ph: 216-778-8526
    Email: kbauchens@metrohealth.org

    Columbus

    Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Howard Safran
    Ph: 401-793-2224
    Email: hsafran@lifespan.org

    Zangmeister Center

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Dayton

    David L. Rike Cancer Center at Miami Valley Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Good Samaritan Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Elyria

    Mercy Cancer Center - Elyria

    Jennifer A Dorth
    Ph: 800-641-2422

    Greenville

    Wayne Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Kettering

    Charles F. Kettering Memorial Hospital

    Howard M. Gross
    Ph: 937-775-1350

    Medina

    Summa Health Center at Lake Medina

    Charles A Kunos
    Ph: 330-375-6101

    Mentor

    Lake/University Ireland Cancer Center

    Jennifer A Dorth
    Ph: 800-641-2422

    Middleburg Heights

    Southwest General Health Center

    Jennifer A Dorth
    Ph: 800-641-2422

    Oregon

    St. Charles Mercy Hospital

    Rex B Mowat
    Ph: 800-444-3561

    Parma

    Parma Community General Hospital

    Jennifer A Dorth
    Ph: 800-641-2422

    Portsmouth

    Southern Ohio Medical Center Cancer Center

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Sylvania

    Flower Hospital Cancer Center

    Rex B Mowat
    Ph: 800-444-3561

    Toledo

    St. Anne Mercy Hospital

    Rex B Mowat
    Ph: 800-444-3561

    University of Toledo Medical Center

    Rex B Mowat
    Ph: 800-444-3561

    Troy

    UVMC Cancer Care Center at Upper Valley Medical Center

    Howard M. Gross
    Ph: 937-775-1350

    Westlake

    UHHS Westlake Medical Center

    Jennifer A Dorth
    Ph: 800-641-2422

    Oklahoma
    Oklahoma City

    Stephenson Cancer Center at the University of Oklahoma

    Terence S. Herman
    Ph: 405-271-4272
    Email: julie-traylor@ouhsc.edu

    Oregon
    Clackamas

    Clackamas Radiation Oncology Center

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

    Portland

    Providence Cancer Center at Providence Portland Medical Center

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

    Providence St. Vincent Medical Center

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

    Salem

    Salem Hospital Regional Cancer Care Services

    John Strother
    Ph: 503-561-2618

    Pennsylvania
    Bryn Mawr

    Bryn Mawr Hospital

    Albert S DeNittis
    Ph: 866-225-5654

    Danville

    Geisinger Cancer Institute at Geisinger Health

    Thomas J Gergel
    Ph: 570-271-5251

    Drexel Hill

    Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Rachelle M. Lanciano
    Ph: 610-284-8237
    Email: jolene.garney@crozer.org

    Dunmore

    Northeast Radiation Oncology Center

    Voichita Bar Ad
    Ph: 215-955-6084

    Paoli

    Cancer Center of Paoli Memorial Hospital

    Albert S DeNittis
    Ph: 866-225-5654

    Philadelphia

    American College of Radiology Imaging Network

    Howard Safran
    Email: hsafran@lifespan.org

    Fox Chase Cancer Center - Philadelphia

    Joshua E Meyer
    Ph: 215-728-4790

    Frankford Hospital Cancer Center - Torresdale Campus

    Voichita Bar Ad
    Ph: 215-955-6084

    Pittsburgh

    UPMC - Shadyside

    Dwight E Heron
    Ph: 412-647-8073

    West Reading

    McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Albert Yuen
    Ph: 610-988-9323

    Wilkes-Barre

    Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Thomas J Gergel
    Ph: 570-271-5251

    Wynnewood

    Lankenau Cancer Center at Lankenau Hospital

    Albert S DeNittis
    Ph: 866-225-5654

    Rhode Island
    Providence

    Rhode Island Hospital Comprehensive Cancer Center

    Howard Safran
    Ph: 401-444-1488

    South Carolina
    Anderson

    AnMed Cancer Center

    John E Doster
    Ph: 864-512-1000

    Charleston

    Hollings Cancer Center at Medical University of South Carolina

    Steve H Chin
    Ph: 843-792-9321

    Greenville

    Cancer Centers of the Carolinas - Andrews

    David L Grisell
    Ph: 864-241-6251

    Cancer Centers of the Carolinas - Faris Road

    David L Grisell
    Ph: 864-241-6251

    CCOP - Greenville

    David L Grisell
    Ph: 864-241-6251

    Greer

    Cancer Centers of the Carolinas - Greer Radiation Oncology

    David L Grisell
    Ph: 864-241-6251

    Seneca

    Cancer Centers of the Carolinas - Seneca

    David L Grisell
    Ph: 864-241-6251

    Spartanburg

    Cancer Centers of the Carolinas - Spartanburg

    David L Grisell
    Ph: 864-241-6251

    Texas
    Galveston

    University of Texas Medical Branch

    Todd A Swanson
    Ph: 409-772-1950
    Email: clinical.research@utmb.edu

    League City

    UTMB Cancer Center at Victory Lakes

    Todd A Swanson
    Ph: 409-772-1950
    Email: clinical.research@utmb.edu

    Lubbock

    Covenant Medical Center

    Paul Joseph Anderson
    Ph: 806-725-8000
    Email: jaccresearch@covhs.org

    Utah
    Murray

    Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    R. Jeffrey Lee
    Ph: 801-507-3950

    Saint George

    Dixie Regional Medical Center - East Campus

    R. Jeffrey Lee
    Ph: 801-507-3950

    Salt Lake City

    Utah Cancer Specialists at UCS Cancer Center

    R. Jeffrey Lee
    Ph: 801-507-3950

    Vermont
    Saint Johnsbury

    Norris Cotton Cancer Center - North

    Bassem I Zaki
    Ph: 800-639-6918
    Email: cancer.research.nurse@dartmouth.edu

    Virginia
    Danville

    Danville Regional Medical Center

    Kiran Patel
    Ph: 434-799-3753

    Washington
    Bremerton

    Harrison Medical Center

    Mehmet S. Copur
    Ph: 800-998-2119

    Longview

    Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center

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

    Vancouver

    Southwest Washington Medical Center Cancer Center

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

    West Virginia
    Charleston

    West Virginia University Medical School - Charleston

    Steven J. Jubelirer
    Ph: 304-344-3457

    Wheeling

    Schiffler Cancer Center at Wheeling Hospital

    Jon David Pollock
    Ph: 304-243-6442

    Wisconsin
    Eau Claire

    Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Rezwan Islam
    Ph: 715-393-1400

    Green Bay

    St. Mary's Hospital Medical Center - Green Bay

    James L Leenstra
    Ph: 920-433-8889

    St. Vincent Hospital Regional Cancer Center

    James L Leenstra
    Ph: 920-433-8889

    Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Mitchell H. Pincus
    Ph: 800-252-2990

    La Crosse

    Gundersen Lutheran Center for Cancer and Blood

    Collin D Driscoll
    Ph: 608-775-2385
    Email: cancerctr@gundluth.org

    Marinette

    Bay Area Cancer Care Center at Bay Area Medical Center

    James L Leenstra
    Ph: 920-433-8889

    Vince Lombardi Cancer Clinic - Marinette

    Mitchell H. Pincus
    Ph: 800-252-2990

    Marshfield

    Saint Joseph's Hospital

    Rezwan Islam
    Ph: 715-393-1400

    Milwaukee

    Froedtert Hospital and Medical College of Wisconsin

    Candice A Johnstone
    Ph: 414-805-4380

    Veterans Affairs Medical Center - Milwaukee

    Elizabeth M. Gore
    Ph: 414-805-4380

    Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Mitchell H. Pincus
    Ph: 800-252-2990

    Minocqua

    Marshfield Clinic - Lakeland Center

    Rezwan Islam
    Ph: 715-393-1400

    New Richmond

    Cancer Center of Western Wisconsin

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

    Rice Lake

    Marshfield Clinic - Indianhead Center

    Rezwan Islam
    Ph: 715-393-1400

    Stevens Point

    Saint Michael's Hospital Cancer Center

    Rezwan Islam
    Ph: 715-393-1400

    Sturgeon Bay

    Door County Cancer Center at Door County Memorial Hospital

    James L Leenstra
    Ph: 920-433-8889

    Summit

    Aurora Medical Center

    Mitchell H. Pincus
    Ph: 800-252-2990

    West Bend

    Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital

    Candice A Johnstone
    Ph: 414-805-4380

    Weston

    Diagnostic and Treatment Center

    Rezwan Islam
    Ph: 715-393-1400

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01196390
    ClinicalTrials.gov processed this data on May 21, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.