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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 IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-01987
RTOG 0848, U10CA021661, NCT01013649

Trial Description

Summary

This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone 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 hydrochloride to adjuvant chemotherapy comprising gemcitabine hydrochloride improves survival as compared to gemcitabine hydrochloride alone following R0 or R1 resection in patients with pancreatic adenocarcinoma.

II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival of patients who have no evidence of progressive disease after 5 courses of gemcitabine hydrochloride-based chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the disease-free survival of patients who are disease-free after 5 courses of adjuvant gemcitabine hydrochloride-based chemotherapy followed by fluoropyrimidine-based chemoradiotherapy.

II. To evaluate the disease-free survival of patients treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride.

III. To evaluate the disease-free and overall survival of patients stratified by wild-type and K-Ras status treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride.

IV. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride in these patients.

V. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without fluoropyrimidine-based chemoradiotherapy in patients who are disease-free after adjuvant gemcitabine hydrochloride-based chemotherapy.

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

VII. To determine the predictive roles of K-Ras mutations and epithelial to mesenchymal transition phenotype in response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibition in early-stage pancreatic cancer.

VIII. To determine the frequency of EGFR-activated pathway and its influence on outcome.

IX. To determine the association between developmental molecular markers and outcome.

X. To determine the phenotype and genotype of tumors in patients with recurrence after resection.

XI. To determine if low baseline fatigue, as measured by the FACIT-Fatigue, predicts survival.

XII. To explore correlations between baseline fatigue, as measured by PROMIS, and survival.

OUTLINE: This is a multicenter study. Patients are stratified according to nodal status (involved vs uninvolved), CA19-9 result (≤ 90 IU/L vs 91-180 IU/L), and surgical margins (positive [R1] vs negative [R0]). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive gemcitabine hydrochloride 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 oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. 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 oral capecitabine twice daily 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed.

After completion of study, patients are followed up periodically.

Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process
  • Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed
  • No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine) tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma, distal bile duct tumor, or ampullary carcinoma
  • Pathologic stage T1-3, N0-1, M0 disease according to American Joint Committee on Cancer (AJCC) 6th edition
  • Has undergone a potentially curative resection (i.e., removal of all gross tumor) involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy within the past 21-56 days
  • Operative report must contain a statement from the surgeon explicitly detailing that a total gross excision of the primary tumor was achieved
  • Pathology report must include documentation of margin status, size of the tumor, and status of the 3 major surgical margins (bile duct, pancreatic parenchyma, and retroperitoneal [uncinate])
  • Post-resection serum CA19-9 =< 180 IU/L
  • Tumor tissue block and peripheral blood samples must be submitted to the study's central tumor bank for correlative studies
  • No recurrent pancreatic cancer
  • Zubrod performance status 0-1
  • ANC >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)
  • Serum total bilirubin =< 2 times upper limit of normal (ULN)
  • Creatinine =< 2 times ULN
  • SGOT =< 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Suitable to receive study radiotherapy, as documented by a radiation oncologist
  • Active HIV infection allowed provided the CD4 count is >= 499/mm^3 and the viral load is =< 50 copies/mL
  • Total oral caloric intake >= 1,500 calories/day
  • No significant nausea and vomiting
  • None of the following severe active comorbidities that would preclude study therapy:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 3 months
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • No other invasive malignancies within the past 2 years except for nonmelanomatous skin cancer or carcinoma in situ
  • See Disease Characteristics
  • No prior systemic chemotherapy for pancreatic cancer
  • Prior chemotherapy for a different cancer allowed
  • No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • Concurrent highly active antiretroviral treatment (HAART) allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Ross AbramsPrincipal Investigator

Trial Sites

U.S.A.
California
  Auburn
 Auburn Radiation Oncology
 Christopher Jones Ph: 916-646-8300
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Raul R. Mena Ph: 818-847-3220
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones Ph: 916-646-8300
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones Ph: 916-646-8300
  Fresno
 California Cancer Center - Woodward Park Office
 Brent L. Kane Ph: 559-447-4050
 Saint Agnes Cancer Center at Saint Agnes Medical Center
 Sri G Gorty Ph: 909-865-9555
  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
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 916-646-8300
 The Permanente Medical Group-Roseville Radiation Oncology
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 Mercy General Hospital
 Christopher Jones Ph: 916-646-8300
 Radiological Associates of Sacramento Medical Group, Incorporated
 Christopher Jones Ph: 916-646-8300
 South Sacramento Cancer Center
 Louis Fehrenbacher Ph: 626-564-3455
  San Diego
 Sharp Memorial Hospital Cancer Center
 Robert M. Barone Ph: 858-939-5015
  San Francisco
 California Pacific Medical Center - California Campus
 Ari D Baron Ph: 650-696-4487
  Email: PazE@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: 916-646-8300
  Vallejo
 Sutter Solano Medical Center
 Ari D Baron Ph: 650-696-4487
  Email: PazE@sutterhealth.org
Colorado
  Aurora
 Rocky Mountain Cancer Centers - Aurora
 Eduardo R. Pajon Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Littleton
 Rocky Mountain Cancer Centers - Littleton
 Eduardo R. Pajon Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Eduardo R. Pajon Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
Connecticut
  Bridgeport
 St. Vincent's Medical Center
 Stuart G Marcus Ph: 203-576-6329
  Email: twhite@stvincents.org
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Robert D. Siegel 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
  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
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
 M.D. Anderson Cancer Center at Orlando
 Daniel J Buchholz Ph: 321-841-7246
Georgia
  Atlanta
 Georgia Cancer Center for Excellence at Grady Memorial Hospital
 Jerome C. Landry Ph: 404-489-9164
  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
 Jeffrey L. Berenberg Ph: 808-586-2979
 Hawaii Medical Center - East
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Stephen C Smith Ph: 215-574-3173
  Twin Falls
 Mountain States Tumor Institute at St. Luke's
 Stephen C Smith Ph: 215-574-3173
Illinois
  Arlington Heights
 Northwest Community Hospital
 Stephen S. Nigh Ph: 847-618-4968
  Chicago
 Creticos Cancer Center at Advocate Illinois Masonic Medical Center
 Deepti A. Singh Ph: 773-296-5360
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 William Small 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
 University of Illinois Cancer Center
 Neeta K Venepalli Ph: 312-355-3046
  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
 Bahman Emami Ph: 708-226-4357
  Naperville
 Edward Hospital Cancer Center
 Alexander Hantel Ph: 630-646-6075
  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
  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
Louisiana
  New Orleans
 CCOP - Ochsner
 Roland B Hawkins Ph: 888-562-4763
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Michael J Burdick Ph: 504-988-6121
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Mayer Gorbaty Ph: 800-888-8823
 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
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Mary U Feng Ph: 800-865-1125
  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
  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
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 P. G. Shankar Giri Ph: 601-815-6700
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Carl E. Freter Ph: 573-882-7440
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Robert L Carolla Ph: 417-269-4520
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 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: 702-731-8274
 Comprehensive Cancer Centers of Nevada - Central Valley
 Raul T Meoz Ph: 702-731-8274
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Daniel W Weed 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
  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
  Ridgewood
 Valley Hospital - Ridgewood
 Thomas J. Rakowski Ph: 201-634-5792
New York
  Albany
 New York Oncology Hematology, PC - Albany
 Vivek S Kavadi Ph: 281-277-5200
  Canandiaqua
 Sands Cancer Center
 Yuhchyau Chen Ph: 585-275-5830
  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
  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
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 John S Salmon Ph: 704-355-2884
  Concord
 Batte Cancer Center at Northeast Medical Center
 John S Salmon Ph: 704-355-2884
  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: 800-641-2422
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 800-641-2422
  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: 502-361-8496
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 502-361-8496
  Elyria
 Mercy Cancer Center - Elyria
 Rex B Mowat Ph: 517-265-0116
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
  Salem
 Cancer Care Center, Incorporated
 William F. Demas Ph: 330-615-4132
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  West Chester
 University Pointe
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Wooster
 Cancer Treatment Center
 William F. Demas Ph: 330-615-4132
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
  Glesham
 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
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Wayne H Pinover Ph: 215-481-2402
  Bryn Mawr
 Bryn Mawr Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  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
  Easton
 Easton Regional Cancer Center at Easton Hospital
 Rajen P Oza 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
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Philadelphia
 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
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  York
 WellSpan Health
 Amit B. Shah Ph: 877-441-7957
Rhode Island
  Providence
 Northmain Radiation Oncology
 Howard Safran Ph: 401-793-2224
 Rhode Island Hospital Comprehensive Cancer Center
 Howard Safran Ph: 401-793-2224
South Carolina
  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
  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
  Amarillo
 Harrington Cancer Center
 Stewart Allen Sharp Ph: 806-359-4673
  Email: ryokubaitis@harringtoncc.org
  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
  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
  Longview
 Longview Cancer Center
 Vivek S Kavadi Ph: 281-277-5200
  San Antonio
 Cancer Care Centers of South Texas - Northeast
 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
  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
 Christopher J Anker 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
  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
  Spokane
 Cancer Care Northwest - Spokane South
 Christopher M Lee Ph: 509-228-1083
  Tacoma
 CCOP - Northwest
 Yoshio Inoue Ph: 253-403-2394
  Vancouver
 Legacy Salmon Creek Medical Center
 Andrew Y Kee Ph: 507-538-7623
 Northwest Cancer Specialists at Vancouver Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
 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: 304-388-9944
  Wheeling
 Schiffler Cancer Center at Wheeling Hospital
 Jon David Pollock Ph: 304-243-6442
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Darryl R. Barton Ph: 877-405-6866
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 Gregory M. Cooley Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Gregory M. Cooley Ph: 920-433-8889
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Beth Ann Erickson Ph: 414-805-4380
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Darryl R. Barton Ph: 877-405-6866
Canada
Ontario
  Ottawa
 Ottawa Hospital Regional Cancer Centre - Civic Campus
 Jason R Pantarotto Ph: 613-761-4395
  Email: info@ohri.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01013649
Information obtained from ClinicalTrials.gov on March 19, 2013

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.