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Clinical Trials (PDQ®)

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

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

Basic Trial Information

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

Trial Sites

U.S.A.
California
  Fresno
 California Cancer Center - Woodward Park Office
 Uma G Swamy Ph: 559-447-4050
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Ross Allen Abrams
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Syma Iqbal Ph: 323-865-0451
 Syma Iqbal Ph: 323-865-0451
  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
 The Permanente Medical Group-Roseville Radiation Oncology
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 South Sacramento Cancer Center
 Louis Fehrenbacher Ph: 626-564-3455
  San Diego
 Rebecca and John Moores UCSD Cancer Center
 Loren K Mell Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  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
Colorado
  Aurora
 Rocky Mountain Cancer Centers - Aurora
 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
  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
  Fort Lauderdale
 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Jacksonville
 Mayo Clinic - Jacksonville
 Michael G. Haddock Ph: 507-538-7623
  Miami
 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
  Gainesville
 Northeast Georgia Medical Center
 Frank G. Lake Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 John A Pablo Ph: 912-819-5704
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
 Michael Russell Mullane Ph: 312-864-6000
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 John P Hayes Ph: 312-695-1301
  Email: cancer@northwestern.edu
 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
  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
  Email: cancer@northwestern.edu
  Peoria
 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
  Springfield
 Cancer Institute at St. John's Hospital
 Cathy L. Clausen 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
Indiana
  Elkhart
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
  Goshen
 Center for Cancer Care at Goshen General Hospital
 James A. Wheeler Ph: 574-535-2858
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Memorial Hospital of South Bend
 Robin Zon Ph: 574-234-5123
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  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
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
 Matthew L Snyder Ph: 866-922-6237
Massachusetts
  Boston
 Boston University Cancer Research Center
 Lisa A. Kachnic Ph: 617-638-8265
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Ross Allen Abrams
  Detroit
 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
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
  Rochester
 Mayo Clinic Cancer Center
 Michael G. Haddock Ph: 507-538-7623
  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
 Alan Philip Lyss Ph: 800-392-0936
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Carl E. Freter Ph: 573-882-7440
  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
 Saint Louis University Cancer Center
 Bruce J. Walz Ph: 314-977-4440
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Jeffrey R Olsen Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 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
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  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
  Las Vegas
 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
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Michael C Hardacre Ph: 775-982-4400
New Jersey
  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
New York
  Brooklyn
 Maimonides Cancer Center at Maimonides Medical Center
 Bernadine Donahue Ph: 718-765-2500
  Glens Falls
 Charles R. Wood Cancer Center at Glens Falls Hospital
 John P Stoutenburg Ph: 518-926-6700
  New York
 Memorial Sloan-Kettering Cancer Center
 Karyn A Goodman Ph: 212-639-7202
  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
  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
  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
 University of Cincinnati
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 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: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  West Chester
 University Pointe
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Matthew C Solhjem Ph: 503-215-6412
  Gresham
 Legacy Mount Hood Medical Center
 Andrew Y Kee Ph: 507-538-7623
  Portland
 CCOP - Columbia River Oncology Program
 Matthew C Solhjem Ph: 503-215-6412
 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
 Providence St. Vincent Medical Center
 Matthew C Solhjem Ph: 503-215-6412
  The Dalles
 Celilo Cancer Center at Mid-Columbia Medical Center
 Keith J. Stelzer Ph: 541-296-7585
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
 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
 Adam C Berger Ph: 215-955-6084
  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
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
  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: 401-793-2224
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
 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
  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
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
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 James L Leenstra Ph: 920-433-8889
Canada
Ontario
  London
 London Regional Cancer Program at London Health Sciences Centre
 Barbara J Fisher Ph: 519-685-8600
  Ottawa
 Ottawa Hospital Regional Cancer Centre - General Campus
 Jason R Pantarotto Ph: 613-761-4395
  Email: info@ohri.ca
Israel
  Tel Hashomer
 Chaim Sheba Medical Center
 Shacham-Shmueli Einat Ph: 011-972-3-6974761
  Email: mop@tasmc.health.gov.il

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01013649
ClinicalTrials.gov processed this data on June 24, 2014

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

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