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Clinical Trials (PDQ®)

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

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

Basic Trial Information

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

Trial Description

Summary

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

Further Study Information

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

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

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

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

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

TERTIARY OBJECTIVES:

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

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

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

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

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

OUTLINE: This is a multicenter study. Patients are stratified according to presence of adenopathy (yes vs no), and involved celiac nodes (absent vs presence ≤ 2 cm). Patients are randomized to 1 of 2 treatment arms.

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

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

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

Patients may undergo blood and tumor tissue samples collection (during surgery) for correlative studies and tissue bank. Patients may complete the Functional Assessment of Cancer Therapy for Esophageal Cancer (FACT-E) and the EuroQol (EQ-5D) questionnaires at baseline and periodically during study.

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

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Howard SafranPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Kirklin Clinic at Acton Road
 Rojymon Jacob Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 Rojymon Jacob Ph: 205-934-0309
Arizona
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Krisha J Howell Ph: 520-626-9008
California
  Burlingame
 Peninsula Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Chico
 Enloe Cancer Center at Enloe Medical Center
 Grace E Yuh Ph: 530-332-3808
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Richard Tuli Ph: 310-423-8965
 USC/Norris Comprehensive Cancer Center and Hospital
 Heinz-Josef Lenz Ph: 323-865-0451
 Heinz-Josef Lenz Ph: 323-865-0451
  Oakland
 Kaiser Permanente-Oakland
 Samantha A Seaward Ph: 626-564-3455
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Chaitali S Nangia Ph: 877-827-8839
  Email: ucstudy@uci.edu
  Rancho Cardova
 Kaiser Permanente Medical Center - Rancho Cordova
 Samantha A Seaward Ph: 626-564-3455
  Rohnert Park
 Rohnert Park Cancer Center
 Samantha A Seaward Ph: 626-564-3455
  Roseville
 The Permanente Medical Group-Roseville Radiation Oncology
 Samantha A Seaward Ph: 626-564-3455
  Sacramento
 South Sacramento Cancer Center
 Samantha A Seaward Ph: 626-564-3455
 Sutter Cancer Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Saint Helena
 Saint Helena Hospital
 David J Tate Ph: 707-967-3698
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Samantha A Seaward Ph: 626-564-3455
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Cancer Treatment Center
 Samantha A Seaward Ph: 626-564-3455
  Vallejo
 Sutter Solano Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
Colorado
  Aurora
 Rocky Mountain Cancer Centers - Aurora
 Eduardo R. Pajon Ph: 888-336-8262
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Denver
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Fort Collins
 Poudre Valley Radiation Oncology
 Joshua H Petit Ph: 970-482-3328
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Eduardo R. Pajon Ph: 888-336-8262
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Samir Narayan Ph: 734-712-3456
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
  New Haven
 Yale Cancer Center
 Bryan W Chang Ph: 203-785-5702
  Norwich
 William W. Backus Hospital
 Dennis E. Slater Ph: 860-886-8362
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Adam Raben Ph: 302-733-6227
 Adam Raben Ph: 302-733-6227
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
  Stuart
 Robert and Carol Weissman Cancer Center at Martin Memorial
 Guillermo Abesada-Terk Ph: 772-288-5858ext4
Georgia
  Atlanta
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
  Fayetteville
 Piedmont Fayette Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
  Gainesville
 Northeast Georgia Medical Center
 Frank G. Lake Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Macon
 Medical Center of Central Georgia
 Frederick M. Schnell Ph: 478-633-1226
  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: 912-819-5704
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-3456
Illinois
  Arlington Heights
 Northwest Community Hospital
 Stephen S. Nigh Ph: 847-618-4968
  Chicago
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 John P Hayes Ph: 312-695-1301
  Email: cancer@northwestern.edu
 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
 Bahman Emami Ph: 708-226-4357
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Elkhart
 Elkhart General Hospital
 David A. Hornback Ph: 800-284-7370
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
 Radiation Oncology Associates Southwest
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Stephen E Rubenstein Ph: 317-851-2555
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 David A. Hornback Ph: 800-284-7370
  Muncie
 Cancer Center at Ball Memorial Hospital
 Yunjie X Lin Ph: 765-751-5850
  Email: alpatterson@medicalconsultantspc.com
  South Bend
 Memorial Hospital of South Bend
 David A. Hornback Ph: 800-284-7370
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Cedar Rapids
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  Clive
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Mark C Smith Ph: 800-237-1225
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Parvesh Kumar Ph: 913-588-4709
  Overland Park
 Kansas City Cancer Centers - Southwest
 Parvesh Kumar Ph: 913-588-4709
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Jyotsna Fuloria Ph: 888-562-4763
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
  Email: wrighd@mmc.org
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Marshall A. Levine Ph: 443-849-3706
 Greenebaum Cancer Center at University of Maryland Medical Center
 Mohan Suntharalingam Ph: 800-888-8823
  Salisbury
 Peninsula Regional Medical Center
 Matthew L Snyder Ph: 866-922-6237
Massachusetts
  Boston
 Boston University Cancer Research Center
 Lisa A. Kachnic Ph: 617-638-8265
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Theodore S Hong
  Email: tshong1@partners.org
 Massachusetts General Hospital
 Theodore S Hong Ph: 877-726-5130
  Burlington
 Lahey Clinic Medical Center - Burlington
 Asa J. Nixon Ph: 781-744-8027
  Milford
 Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
 Michael Constantine Ph: 215-574-3173
  Pittsfield
 Berkshire Hematology Oncology, PC
 Harvey Zimbler Ph: 413-496-8205
  Email: ggero@bhs1.org
  South Weymouth
 Dana-Farber/Brigham and Women's Cancer Center at South Shore
 Rolf Freter Ph: 617-376-6400
  Email: koneil@shcpo.shields.com
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-3456
 University of Michigan Comprehensive Cancer Center
 Howard Safran
 James A. Hayman Ph: 800-865-1125
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Eleanor M. Walker Ph: 313-916-1784
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Samir Narayan Ph: 734-712-3456
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Livonia
 St. Mary Mercy Hospital
 Samir Narayan Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Samir Narayan Ph: 734-712-3456
  Southfield
 Providence Hospital - Southfield
 Michael J. Kraut Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-3456
Minnesota
  Duluth
 Miller - Dwan Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Maplewood
 Minnesota Oncology - Maplewood
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Michael G. Haddock Ph: 507-538-7623
  Saint Paul
 Regions Hospital Cancer Care Center
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Chesterfield
 Saint Luke's Hospital
 Donald F. Busiek Ph: 314-205-6936
  Kansas City
 Kansas City Cancer Centers - North
 Parvesh Kumar Ph: 913-588-4709
 Kansas City Cancer Centers - South
 Parvesh Kumar Ph: 913-588-4709
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Lee's Summit
 Kansas City Cancer Centers - East
 Parvesh Kumar Ph: 913-588-4709
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Rolla
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Louis
 Barnes-Jewish West County Hospital
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Saint Peters
 Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
Nevada
  Las Vegas
 Comprehensive Cancer Centers of Nevada - Central Valley
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Downtown Location
 John Allan Ellerton Ph: 702-384-0013
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Michael C Hardacre Ph: 775-982-4400
New Hampshire
  Concord
 Payson Center for Cancer Care at Concord Hospital
 Su K Metcalfe Ph: 800-441-1138
  Dover
 Seacoast Cancer Center at Wentworth - Douglass Hospital
 Taylor M Ortiz Ph: 603-740-2150
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Sucha O Asbell Ph: 856-325-6757
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Mona Karim Ph: 973-971-5900
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Lemuel S. Ariaratnam Ph: 888-847-8823
  Newark
 UMDNJ University Hospital
 Sabin B Motwani Ph: 732-235-8675
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Voichita Bar Ad Ph: 215-955-6084
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Sucha O Asbell Ph: 856-325-6757
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Howard Safran
New York
  Bronx
 Montefiore Medical Center
 Lakshmi Rajdev Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Glens Falls
 Charles R. Wood Cancer Center at Glens Falls Hospital
 Eric A Pillemer Ph: 518-926-6700
  New York
 Beth Israel Medical Center - Petrie Division
 Peter Kozuch Ph: 212-844-6286
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Balazs Halmos Ph: 212-305-8615
 St. Luke's - Roosevelt Hospital Center - St.Luke's Division
 Peter Kozuch Ph: 212-844-6286
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Jonathan C Salo Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Concord
 Batte Cancer Center at Northeast Medical Center
 Jonathan C Salo Ph: 704-355-2884
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Monroe
 Edwards Cancer Center at Union Regional Medical Center
 Jonathan C Salo Ph: 704-355-2884
  Raleigh
 Rex Cancer Center at Rex Hospital
 Oludamilola A Olajide Ph: 919-784-7209
North Dakota
  Minot
 Trinity CancerCare Center
 Kevin Basil Collins Ph: 800-862-0005
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Cincinnati
 University of Cincinnati
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Case Comprehensive Cancer Center
 Jennifer A Dorth Ph: 800-641-2422
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce J. Averbook Ph: 216-778-8526
  Email: kbauchens@metrohealth.org
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Howard Safran
 Evan J Wuthrick Ph: 866-627-7616
  Email: osu@emergingmed.com
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Dayton
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 765-983-3000
 Good Samaritan Hospital
 Howard M. Gross Ph: 765-983-3000
  Elyria
 Mercy Cancer Center - Elyria
 Jennifer A Dorth Ph: 800-641-2422
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 765-983-3000
  Medina
 Summa Health Center at Lake Medina
 Charles A Kunos Ph: 330-375-6101
  Mentor
 Lake/University Ireland Cancer Center
 Jennifer A Dorth Ph: 800-641-2422
  Middleburg Heights
 Southwest General Health Center
 Jennifer A Dorth Ph: 800-641-2422
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Jennifer A Dorth Ph: 800-641-2422
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 765-983-3000
  West Chester
 University Pointe
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Westlake
 UHHS Westlake Medical Center
 Jennifer A Dorth Ph: 800-641-2422
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
  Portland
 CCOP - Columbia River Oncology Program
 Howard Safran
 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
  Salem
 Salem Hospital Regional Cancer Care Services
 John Strother Ph: 503-561-2618
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Rachelle M. Lanciano Ph: 610-284-8237
  Email: jolene.garney@crozer.org
  Dunmore
 Northeast Radiation Oncology Center
 Voichita Bar Ad Ph: 215-955-6084
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 American College of Radiology Imaging Network
 Howard Safran
  Email: hsafran@lifespan.org
 Fox Chase Cancer Center - Philadelphia
 Joshua E Meyer Ph: 215-728-4790
 Frankford Hospital Cancer Center - Torresdale Campus
 Voichita Bar Ad Ph: 215-955-6084
  Pittsburgh
 UPMC - Shadyside
 Dwight E Heron Ph: 412-647-8073
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Thomas J Gergel Ph: 570-271-5251
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
Rhode Island
  Providence
 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
 Steve H Chin Ph: 843-792-9321
  Greenville
 Cancer Centers of the Carolinas - Andrews
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 A. Bapsi Chakravarthy Ph: 800-811-8480
Texas
  Galveston
 University of Texas Medical Branch
 Todd A Swanson Ph: 409-772-1950
  Email: clinical.research@utmb.edu
  Houston
 Methodist Hospital
 Alexandra Phan Ph: 713-790-2700
  League City
 UTMB Cancer Center at Victory Lakes
 Todd A Swanson Ph: 409-772-1950
  Email: clinical.research@utmb.edu
  Lubbock
 Covenant Medical Center
 Paul Joseph Anderson Ph: 806-725-8000
  Email: jaccresearch@covhs.org
Utah
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 R. Jeffrey Lee Ph: 801-507-3950
  Salt Lake City
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee Ph: 801-507-3950
Washington
  Bellingham
 St. Joseph Cancer Center
 Michael Andre Taylor Ph: 360-788-8223
  Email: cpatz@peacehealth.org
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 George E. Laramore Ph: 206-616-8289
  Seattle
 Seattle Cancer Care Alliance
 George E. Laramore Ph: 206-616-8289
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 University Cancer Center at University of Washington Medical Center
 George E. Laramore Ph: 206-616-8289
  Tacoma
 CCOP - Northwest
 Yoshio Inoue Ph: 253-403-2394
  Vancouver
 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
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Michael Husak Ph: 715-236-8100
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 James L Leenstra Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Collin D Driscoll Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 James L Leenstra Ph: 920-433-8889
 Vince Lombardi Cancer Clinic - Marinette
 Mitchell H. Pincus Ph: 800-252-2990
  Marshfield
 Saint Joseph's Hospital
 Michael Husak Ph: 715-236-8100
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Candice A Johnstone Ph: 414-805-4380
  Email: cancerhelp@dartmouth.edu
 Veterans Affairs Medical Center - Milwaukee
 Elizabeth M. Gore Ph: 888-469-6614
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  Minocqua
 Marshfield Clinic - Lakeland Center
 Michael Husak Ph: 715-236-8100
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Michael Husak Ph: 715-236-8100
  Stevens Point
 Saint Michael's Hospital Cancer Center
 Michael Husak Ph: 715-236-8100
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 James L Leenstra Ph: 920-433-8889
  Summit
 Aurora Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  West Bend
 Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital
 Candice A Johnstone Ph: 414-805-4380
  Email: cancerhelp@dartmouth.edu
  Weston
 Diagnostic and Treatment Center
 Michael Husak Ph: 715-236-8100

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01196390
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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