Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-01987
RTOG-0848, CDR0000659092, U10CA180868, U10CA021661, NCT01013649

Trial Description

Summary

This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy. (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 cycles of adjuvant chemotherapy.

II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma.

III. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma.

IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy.

V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present.

VI. To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival.

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

ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. (NOTE: Phase II-R erlotinib hydrochloride randomization completed, Arm 2 closed to accrual effective 2/19/2014)

Patients with no disease progression after treatment in arm I or II are then stratified according to their first randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment arms (arm III or IV).

ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II.

ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria

Inclusion Criteria:

  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
  • The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
  • Interval between definitive tumor-related surgery and 1st step registration between 21-70 days
  • Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible
  • Zubrod performance status 0 or 1
  • Complete history and physical examination including weight and Zubrod status within 31 days of study entry
  • Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
  • Post resection serum cancer antigen (CA)19-9 =< 180 units/mL within 21 days of registration on study
  • Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study
  • Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study
  • Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study
  • Negative serum pregnancy test for women of childbearing potential within 14 days of study registration
  • Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study; patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead
  • Signed study-specific informed consent
  • Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol
  • Women of childbearing potential and male participants must practice adequate contraception
  • Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed

Exclusion Criteria:

  • Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely IPMN with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible
  • Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
  • Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (patients with a previous history of carcinoma in situ are eligible)
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the 3 months of study 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
  • Pregnant or lactating women
  • Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Ross Abrams, Principal Investigator

    Trial Sites

    U.S.A.

    California
    Auburn

    Auburn Radiation Oncology

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

    Burbank

    Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

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

    Burlingame

    Peninsula Medical Center

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

    Cameron Park

    Radiation Oncology Centers - Cameron Park

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

    Fresno

    California Cancer Center - Woodward Park Office

    Uma G Swamy
    Ph: 559-447-4050

    Fresno Cancer Center

    Louis Fehrenbacher
    Ph: 626-564-3455

    Greenbrae

    Marin Cancer Institute at Marin General Hospital

    Lloyd T Miyawaki
    Ph: 415-925-7325

    La Jolla

    Rebecca and John Moores UCSD Cancer Center

    Ross Allen Abrams
    Ph: 312-942-5498

    Los Angeles

    Kaiser Permanente Medical Center - Los Angeles

    Michael R Girvigian
    Ph: 626-564-3455

    Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Nicholas N Nissen
    Ph: 310-423-8965

    USC/Norris Comprehensive Cancer Center and Hospital

    Syma Iqbal
    Ph: 323-865-0451

    Syma Iqbal
    Ph: 323-865-0451

    Modesto

    Memorial Medical Center

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

    Oakland

    Alta Bates Summit Medical Center - Summit Campus

    James H. Feusner
    Ph: 510-450-7600

    CCOP - Bay Area Tumor Institute

    James H. Feusner
    Ph: 510-450-7600

    Kaiser Permanente-Oakland

    Louis Fehrenbacher
    Ph: 626-564-3455

    Orange

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

    Tara E Seery
    Ph: 877-827-8839
    Email: ucstudy@uci.edu

    Rancho Cardova

    Kaiser Permanente Medical Center - Rancho Cordova

    Louis Fehrenbacher
    Ph: 626-564-3455

    Rohnert Park

    Rohnert Park Cancer Center

    Louis Fehrenbacher
    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

    Louis Fehrenbacher
    Ph: 626-564-3455

    Sacramento

    South Sacramento Cancer Center

    Louis Fehrenbacher
    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

    San Diego

    Sharp Memorial Hospital Cancer Center

    Robert M. Barone
    Ph: 858-939-5015

    San Francisco

    California Pacific Medical Center - California Campus

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

    Santa Clara

    Kaiser Permanente Medical Center - Santa Clara Homestead Campus

    Louis Fehrenbacher
    Ph: 626-564-3455

    South San Francisco

    Kaiser Permanente Cancer Treatment Center

    Louis Fehrenbacher
    Ph: 626-564-3455

    Vacaville

    Solano Radiation Oncology Center

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

    Vallejo

    Sutter Solano Medical Center

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

    Colorado
    Aurora

    Rocky Mountain Cancer Centers - Aurora

    Keren Sturtz
    Ph: 888-785-6789

    Boulder

    Rocky Mountain Cancer Centers-Boulder

    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

    Greeley

    North Colorado Medical Center

    Keren Sturtz
    Ph: 888-785-6789

    Littleton

    Rocky Mountain Cancer Centers - Littleton

    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

    Keren Sturtz
    Ph: 888-785-6789

    Wheat Ridge

    Exempla Lutheran Medical Center

    Keren Sturtz
    Ph: 888-785-6789

    Connecticut
    Bridgeport

    St. Vincent's Medical Center

    Christine Van Cott
    Ph: 203-576-6329
    Email: twhite@stvincents.org

    Hartford

    Helen and Harry Gray Cancer Center at Hartford Hospital

    Andrew L Salner
    Ph: 860-545-5363

    New Britain

    George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    Neal B Goldberg
    Ph: 860-224-5660

    Delaware
    Newark

    Helen F. Graham Cancer Center at Christiana Hospital

    Adam Raben
    Ph: 302-733-6227

    Florida
    Deerfield Beach

    University of Miami/Deerfield Beach

    Lorraine Portelance
    Ph: 866-574-5124
    Email: Sylvester@emergingmed.com

    Miami

    Jackson Memorial Hospital

    Lorraine Portelance
    Ph: 866-574-5124
    Email: Sylvester@emergingmed.com

    University of Miami Sylvester Comprehensive Cancer Center - Miami

    Lorraine Portelance
    Ph: 866-574-5124
    Email: Sylvester@emergingmed.com

    Miami Beach

    CCOP - Mount Sinai Medical Center

    Michael Schwartz
    Ph: 305-674-2625
    Email: info@msccop.com

    Orlando

    M.D. Anderson Cancer Center at Orlando

    Daniel J Buchholz
    Ph: 321-841-7246
    Email: CancerClinicalTrials@orlandohealth.com

    Georgia
    Atlanta

    Emory University Hospital Midtown

    Bassel F El-Rayes
    Ph: 404-778-1868

    Saint Joseph's Hospital of Atlanta

    Bassel F El-Rayes
    Ph: 404-778-1868

    Winship Cancer Institute of Emory University

    Bassel F El-Rayes
    Ph: 404-778-1868

    Gainesville

    Northeast Georgia Medical Center

    Frank G. Lake
    Ph: 770-219-8800
    Email: cancerpatient.navigator@nghs.com

    Savannah

    Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Aaron W Pederson
    Ph: 912-350-8568

    Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    John A Pablo
    Ph: 800-622-6877

    Hawaii
    Honolulu

    Cancer Research Center of Hawaii

    Paul A. DeMare
    Ph: 808-545-8548

    Hawaii Medical Center - East

    Paul A. DeMare
    Ph: 808-545-8548

    Queen's Cancer Institute at Queen's Medical Center

    Paul A. DeMare
    Ph: 808-545-8548

    Idaho
    Boise

    Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Stephen C Smith
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Twin Falls

    Mountain States Tumor Institute at St. Luke's

    Stephen C Smith
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Illinois
    Arlington Heights

    Northwest Community Hospital

    Stephen S. Nigh
    Ph: 847-618-4968

    Chicago

    John H. Stroger, Jr. Hospital of Cook County

    Thomas E. Lad
    Ph: 312-864-6000

    Rush Cancer Institute at Rush University Medical Center

    Ross Allen Abrams
    Ph: 312-942-5498
    Email: clinical_trials@rush.edu

    University of Chicago Cancer Research Center

    Stanley L Liauw
    Ph: 773-834-7424

    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

    Harvey

    Ingalls Cancer Care Center at Ingalls Memorial Hospital

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

    Maywood

    Cardinal Bernardin Cancer Center at Loyola University Medical Center

    William Small
    Ph: 708-226-4357

    Naperville

    Edward Hospital Cancer Center

    Alexander Hantel
    Ph: 630-646-6075

    Pekin

    Cancer Treatment Center at Pekin Hospital

    Nguyet A Le-Lindqwister
    Ph: 800-793-2262

    Peoria

    Methodist Medical Center of Illinois

    Nguyet A Le-Lindqwister
    Ph: 800-793-2262

    OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

    Nguyet A Le-Lindqwister
    Ph: 800-793-2262

    OSF St. Francis Medical Center

    Nguyet A Le-Lindqwister
    Ph: 800-793-2262

    Peru

    Valley Cancer Center

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

    Springfield

    Cancer Institute at St. John's Hospital

    Laurent Brard
    Ph: 217-525-5666
    Email: diana.weyhenmeyer@st-johns.org

    Regional Cancer Center at Memorial Medical Center

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

    Urbana

    Carle Cancer Center at Carle Foundation Hospital

    Kalika P. Sarma
    Ph: 800-446-5532

    Warrenville

    Central Dupage Cancer Center

    Christopher M. George
    Ph: 630-208-4563
    Email: kevin.tomczyk@delnor.com

    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

    Mishawaka

    Michiana Hematology-Oncology, PC - Mishawaka

    Robin Zon
    Ph: 574-234-5123

    South Bend

    CCOP - Northern Indiana CR Consortium

    Robin Zon
    Ph: 574-234-5123

    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

    Medical Oncology and Hematology Associates at Mercy Cancer Center

    Mehmet S. Copur
    Ph: 800-998-2119

    Mercy Cancer Center at Mercy Medical Center - Des Moines

    Mehmet S. Copur
    Ph: 800-998-2119

    Sioux City

    Siouxland Hematology-Oncology Associates, LLP

    Donald Bruce Wender
    Ph: 712-252-0088

    Kansas
    Topeka

    Cotton-O'Neil Cancer Center

    David E Einspahr
    Ph: 785-270-4963

    Wichita

    Via Christi Cancer Center at Via Christi Regional Medical Center

    Shaker R. Dakhil
    Ph: 316-262-4467

    Kentucky
    Lexington

    Central Baptist Hospital

    Firas B Badin
    Ph: 859-260-6425

    University of Kentucky Chandler Medical Center

    Mahesh Kudrimoti
    Ph: 859-257-3379

    Louisiana
    New Orleans

    Ochsner Cancer Institute at Ochsner Clinic Foundation

    Roland B Hawkins
    Ph: 888-562-4763

    Tulane Cancer Center at Tulane University Hospital and Clinic

    William R. Robinson
    Ph: 504-988-6121

    Maryland
    Baltimore

    Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Mayer Gorbaty
    Ph: 410-601-6120
    Email: pridgely@lifebridgehealth.org

    Greenebaum Cancer Center at University of Maryland Medical Center

    William F. Regine
    Ph: 800-888-8823

    St. Agnes Hospital Cancer Center

    Richard S. Hudes
    Ph: 410-368-2910

    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

    Burlington

    Lahey Clinic Medical Center - Burlington

    Keith Ellis Stuart
    Ph: 781-744-8027

    Fall River

    Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Raymond L Dugal
    Ph: 877-726-5130

    Springfield

    Baystate Medical Center

    Seth A Kaufman
    Ph: 413-794-9338

    Michigan
    Adrian

    Hickman Cancer Center at Bixby Medical Center

    Rex B Mowat
    Ph: 800-444-3561

    Ann Arbor

    University of Michigan Comprehensive Cancer Center

    Ross Allen Abrams
    Ph: 312-942-5498

    Clinton Township

    Henry Ford Macomb Hospital

    Eleanor M. Walker
    Ph: 313-916-1784

    Detroit

    Josephine Ford Cancer Center at Henry Ford Hospital

    Eleanor M. Walker
    Ph: 313-916-1784

    Wayne State University

    Andre A. Konski
    Ph: 313-576-9363

    Farmington Hills

    Weisberg Cancer Treatment Center

    Andre A. Konski
    Ph: 313-576-9363

    Kalamazoo

    West Michigan Cancer Center

    Raymond Sterling Lord
    Ph: 269-373-7458

    Royal Oak

    William Beaumont Hospital - Royal Oak Campus

    Laura M Nadeau
    Ph: 248-551-7695

    Trenton

    Down River Center for Oncology

    Eleanor M. Walker
    Ph: 313-916-1784

    Troy

    William Beaumont Hospital - Troy Campus

    Laura M Nadeau
    Ph: 248-551-7695

    West Bloomfield

    Henry Ford Medical Center - West Bloomfield

    Eleanor M. Walker
    Ph: 313-916-1784

    Minnesota
    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

    Saint Paul

    Regions Hospital Cancer Care Center

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

    United Hospital

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

    Missouri
    Cape Girardeau

    Southeast Cancer Center

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

    Columbia

    Ellis Fischel Cancer Center at University of Missouri - Columbia

    Donald C Doll
    Ph: 573-882-7440

    Rolla

    Phelps County Regional Medical Center

    Jay W Carlson
    Ph: 800-821-7532

    Saint Louis

    Barnes-Jewish West County Hospital

    Jeffrey R Olsen
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    Missouri Baptist Cancer Center

    Alan Philip Lyss
    Ph: 800-392-0936

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Jeffrey R Olsen
    Ph: 800-600-3606
    Email: info@siteman.wustl.edu

    Saint Peters

    Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

    Jeffrey R Olsen
    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

    St. Vincent Healthcare Cancer Care Services

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    Kalispell

    Kalispell Regional Medical 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

    Fishel Z Liberman
    Ph: 308-865-7963

    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

    CCOP - Nevada Cancer Research Foundation

    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
    Manchester

    Elliot Regional Cancer Center at Elliot Hospital

    Brian R Knab
    Ph: 603-663-1800

    New Jersey
    Basking Ridge

    Memorial Sloan-Kettering Cancer Center - Basking Ridge

    Karyn A Goodman
    Ph: 212-639-7202

    Camden

    Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Ashish B Patel
    Ph: 856-325-6757

    Livingston

    St. Barnabas Medical Center Cancer Center

    Delia Radovich
    Ph: 973-322-2470

    Mount Holly

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

    Lemuel S. Ariaratnam
    Ph: 888-847-8823

    Newark

    Newark Beth Israel Medical Center

    Charles S Cathcart
    Ph: 973-926-7230

    Sparta

    Frederick R. and Betty M. Smith Cancer Treatment Center

    Adam C Berger
    Ph: 215-955-6084

    Voorhees

    Cancer Institute of New Jersey at Cooper - Voorhees

    Ashish B Patel
    Ph: 856-325-6757

    New York
    Commack

    Memorial Sloan-Kettering Cancer Center

    Karyn A Goodman
    Ph: 212-639-7202

    Glens Falls

    Charles R. Wood Cancer Center at Glens Falls Hospital

    John P Stoutenburg
    Ph: 518-926-6700

    Middletown

    Tucker Center for Cancer Care at Orange Regional Medical Center

    Jeffrey M. Stewart
    Ph: 845-342-7609

    New York

    Memorial Sloan-Kettering Cancer Center

    Karyn A Goodman
    Ph: 212-639-7202

    New York University Medical Center

    Silvia C Formenti
    Ph: 212-263-4434
    Email: prmc.coordinator@nyumc.org

    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

    Rockville Centre

    Memorial Sloan-Kettering Cancer Center - Rockville Centre

    Karyn A Goodman
    Ph: 212-639-7202

    Sleepy Hollow

    Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

    Karyn A Goodman
    Ph: 212-639-7202

    North Carolina
    Greenville

    Leo W. Jenkins Cancer Center at ECU Medical School

    Clinton H Leinweber
    Ph: 252-744-2391

    Kinston

    Kinston Medical Specialists

    Peter R. Watson
    Ph: 252-559-2200

    Matthews

    Southeast Radiation Oncology Group, PA at Matthews Radiation Oncology Center

    Justin P Favaro
    Ph: 704-384-5369

    Raleigh

    Rex Cancer Center at Rex Hospital

    Justin J Wu
    Ph: 919-784-7209

    Ohio
    Akron

    McDowell Cancer Center at Akron General Medical Center

    Mitchell Lee Fromm
    Ph: 330-344-6348

    Summa Center for Cancer Care at Akron City Hospital

    Charles A Kunos
    Ph: 330-375-6101

    Barberton

    Barberton Citizens Hospital

    Charles A Kunos
    Ph: 330-375-6101

    Cincinnati

    Bethesda North Hospital

    Mehmet S. Copur
    Ph: 800-998-2119

    Cleveland

    Cleveland Clinic Cancer Center at Fairview Hospital

    Andrew D Vassil
    Ph: 866-223-8100

    Cleveland Clinic Taussig Cancer Center

    Andrew D Vassil
    Ph: 866-223-8100

    MetroHealth Cancer Care Center at MetroHealth Medical Center

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

    Columbus

    Grant Medical Center Cancer Care

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

    Riverside Methodist Hospital Cancer Care

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

    Zangmeister Center

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

    Independence

    Cleveland Clinic Taussig Cancer Center

    Andrew D Vassil
    Ph: 866-223-8100

    Maumee

    Northwest Ohio Oncology Center

    Rex B Mowat
    Ph: 800-444-3561

    Mayfield Heights

    Hillcrest Cancer Center at Hillcrest Hospital

    Andrew D Vassil
    Ph: 866-223-8100

    Medina

    Summa Health Center at Lake Medina

    Charles A Kunos
    Ph: 330-375-6101

    Ravenna

    Robinson Radiation Oncology

    Mitchell Lee Fromm
    Ph: 330-344-6348

    Sandusky

    North Coast Cancer Care, Incorporated

    Andrew D Vassil
    Ph: 866-223-8100

    Strongsville

    Cleveland Clinic Foundation - Strongsville

    Andrew D Vassil
    Ph: 866-223-8100

    Sylvania

    Flower Hospital Cancer Center

    Jeffrey H Muler
    Ph: 419-824-1842

    Toledo

    University of Toledo Medical Center

    Rex B Mowat
    Ph: 800-444-3561

    Wooster

    Cleveland Clinic - Wooster

    Andrew D Vassil
    Ph: 866-223-8100

    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

    Gresham

    Legacy Mount Hood Medical Center

    Andrew Y Kee
    Ph: 507-538-7623

    Portland

    Legacy Good Samaritan Hospital & Comprehensive Cancer Center

    Andrew Y Kee
    Ph: 507-538-7623

    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

    Pennsylvania
    Abington

    Rosenfeld Cancer Center at Abington Memorial Hospital

    Wayne H Pinover
    Ph: 215-481-2402

    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

    Adam C Berger
    Ph: 215-955-6084

    Easton

    Easton Regional Cancer Center at Easton Hospital

    Sonyo Shin
    Ph: 610-250-4000

    Gettysburg

    Adams Cancer Center

    Amit B. Shah
    Ph: 877-441-7957

    Hanover

    Cherry Tree Cancer Center

    Amit B. Shah
    Ph: 877-441-7957

    Media

    Riddle Memorial Hospital Cancer Center

    Albert S DeNittis
    Ph: 866-225-5654

    Paoli

    Cancer Center of Paoli Memorial Hospital

    Albert S DeNittis
    Ph: 866-225-5654

    Philadelphia

    Frankford Hospital Cancer Center - Torresdale Campus

    Adam C Berger
    Ph: 215-955-6084

    Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Adam C Berger
    Ph: 215-955-6084

    Sayre

    Guthrie Cancer Center at Guthrie Clinic Sayre

    Bradley W Lash
    Ph: 800-836-0388

    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

    York

    WellSpan Health

    Amit B. Shah
    Ph: 877-441-7957

    Rhode Island
    Providence

    Rhode Island Hospital Comprehensive Cancer Center

    Howard Safran
    Ph: 401-444-1488

    South Carolina
    Anderson

    AnMed Cancer Center

    Patricia C Griffin
    Ph: 800-486-5941

    Charleston

    Hollings Cancer Center at Medical University of South Carolina

    David T Marshall
    Ph: 843-792-9321

    Greenville

    Cancer Centers of the Carolinas - Faris Road

    David L Grisell
    Ph: 864-241-6251

    CCOP - Greenville

    David L Grisell
    Ph: 864-241-6251

    Greer

    Cancer Centers of the Carolinas - Greer Radiation Oncology

    David L Grisell
    Ph: 864-241-6251

    Gibbs Cancer Center-Pelham

    Patricia C Griffin
    Ph: 800-486-5941

    Seneca

    Cancer Centers of the Carolinas - Seneca

    David L Grisell
    Ph: 864-241-6251

    Spartanburg

    Cancer Centers of the Carolinas - Spartanburg

    David L Grisell
    Ph: 864-241-6251

    Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Patricia C Griffin
    Ph: 800-486-5941

    South Dakota
    Rapid City

    Rapid City Regional Hospital

    Michael J Swartz
    Ph: 605-716-3982
    Email: research@rcrh.org

    Tennessee
    Nashville

    Vanderbilt-Ingram Cancer Center

    A. Bapsi Chakravarthy
    Ph: 800-811-8480

    Texas
    Arlington

    Texas Oncology, PA at Texas Cancer Center - Arlington South

    Vivek S Kavadi
    Ph: 281-277-5200

    Austin

    Texas Oncology - Midtown Austin

    Vivek S Kavadi
    Ph: 281-277-5200

    Texas Oncology, PA at South Austin Cancer Center

    Vivek S Kavadi
    Ph: 281-277-5200

    Texas Oncology, PA at Texas Oncology Cancer Center - Central

    Vivek S Kavadi
    Ph: 281-277-5200

    Bedford

    Texas Oncology, PA at Harris Center HEB

    Vivek S Kavadi
    Ph: 281-277-5200

    Fort Worth

    Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

    Vivek S Kavadi
    Ph: 281-277-5200

    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

    Longview

    Longview Cancer Center

    Vivek S Kavadi
    Ph: 281-277-5200

    Round Rock

    Texas Oncology, PA - Seton Williamson

    Vivek S Kavadi
    Ph: 281-277-5200

    Texas Oncology, PA at Texas Cancer Center Round Rock

    Vivek S Kavadi
    Ph: 281-277-5200

    Sherman

    Texas Oncology, PA at Texas Cancer Center - Sherman

    Vivek S Kavadi
    Ph: 281-277-5200

    Sugar Land

    Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

    Vivek S Kavadi
    Ph: 281-277-5200

    Tyler

    Tyler Cancer Center

    Vivek S Kavadi
    Ph: 281-277-5200

    Utah
    American Fork

    American Fork Hospital

    R. Jeffrey Lee
    Ph: 801-507-3950

    Logan

    Logan Regional Hospital

    R. Jeffrey Lee
    Ph: 801-507-3950

    Murray

    Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    R. Jeffrey Lee
    Ph: 801-507-3950

    Ogden

    Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    R. Jeffrey Lee
    Ph: 801-507-3950

    Provo

    Utah Valley Regional Medical Center - Provo

    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

    Huntsman Cancer Institute at University of Utah

    Jonathan D Tward
    Ph: 801-581-4477
    Email: clinical.trials@hci.utah.edu

    Utah Cancer Specialists at UCS Cancer Center

    R. Jeffrey Lee
    Ph: 801-507-3950

    Virginia
    Hampton

    Sentara Cancer Institute at Sentara CarePlex Hospital

    Scott S Williams
    Ph: 757-388-2406

    Norfolk

    Sentara Cancer Institute at Sentara Norfolk General Hospital

    Scott S Williams
    Ph: 757-388-2406

    Virginia Beach

    Coastal Cancer Center at Sentara Virginia Beach General Hospital

    Scott S Williams
    Ph: 757-388-2406

    Washington
    Gig Harbor

    Tacoma/Valley Radiation Oncology Centers-Gig Harbor

    John A Keech
    Ph: 907-458-5380

    Longview

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

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

    Puyallup

    Takoma/Valley Radiation Oncology Center at Good Samaritan

    John A Keech
    Ph: 907-458-5380

    Tacoma

    Northwest Medical Specialties, PLLC - Tacoma

    Yoshio Inoue
    Ph: 253-403-2394

    Tacoma/Valley Radiation Oncology Center - St. Joseph

    John A Keech
    Ph: 907-458-5380

    Vancouver

    Legacy Salmon Creek Medical Center

    Andrew Y Kee
    Ph: 507-538-7623

    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
    Green Bay

    St. Mary's Hospital Medical Center - Green Bay

    James L Leenstra
    Ph: 920-433-8889

    St. Vincent Hospital Regional Cancer Center

    James L Leenstra
    Ph: 920-433-8889

    La Crosse

    Gundersen Lutheran Center for Cancer and Blood

    Kurt Oettel
    Ph: 608-775-2385
    Email: cancerctr@gundluth.org

    Marinette

    Bay Area Cancer Care Center at Bay Area Medical Center

    James L Leenstra
    Ph: 920-433-8889

    Milwaukee

    Froedtert Hospital and Medical College of Wisconsin

    Beth Ann Erickson
    Ph: 414-805-4380

    Sturgeon Bay

    Door County Cancer Center at Door County Memorial Hospital

    James L Leenstra
    Ph: 920-433-8889

    Israel

    Petach Tikva

    Rabin Medical Center - Beilinson Campus

    Salomon M Stemmer
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Tel Aviv

    Tel-Aviv Sourasky Medical Center

    Ravit Geva
    Ph: 011-972-3-6974761
    Email: mop@tasmc.health.gov.il

    Tel Hashomer

    Chaim Sheba Medical Center

    Shacham-Shmueli Einat
    Ph: 972 3 530-5943

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01013649
    ClinicalTrials.gov processed this data on May 20, 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.