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Clinical Trials (PDQ®)

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherA011202
U10CA031946, NCI-2013-00875, NCT01901094

Trial Description

Summary

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy alone in treating patients with node-positive breast cancer previously treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Further Study Information

All patients will undergo surgery to identify sentinel lymph node(s). If a sentinel lymph node is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. Patients whose sentinel lymph is found to be negative intra-operatively and have not undergone ALND, but had at least one sentinel lymph node found to be positive on final pathology review will be registered/randomized post-operatively. After patient registration/randomization, if negative surgical margins are not achieved at the completion of all breast surgeries then the patient will discontinue protocol treatment.

Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion.

Patients with HER 2 positive disease (on tumor markers obtained either prior to NAC or on surgical pathology) should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period). Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed. Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation.

Primary Objective:

  • To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy

Secondary Objectives:

  • To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy
  • To obtain an estimate of the distribution of residual disease burden scores.
  • To estimate the distribution of overall survival.

Patients are followed up for 5 years after completion of radiation therapy.

Eligibility Criteria

Pre-Registration Eligibility Criteria:

  • Patients ≥ 18 years of age
  • Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition.
  • No inflammatory breast cancer.
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to neoadjuvant chemotherapy.
  • Patients must have had estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy.
  • Patients must have completed all planned chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Patients must have completed at least 6 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes.
  • Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial.
  • All patients must have a clinically negative axilla (no palpable lymph nodes or bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy.
  • No neoadjuvant endocrine therapy.
  • No neoadjuvant radiation therapy.
  • No sentinel lymph node (SLN) surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy.
  • No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]). Lobular carcinoma in situ (LCIS) and benign breast disease is allowed.
  • No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
  • No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.
  • Patients must not be pregnant or nursing. A negative pregnancy test is required prior to registration for women of childbearing potential. Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential.
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1.
  • Required Pre-Registration Laboratory Values:

1. Serum or urine beta-human chorionic gonadotropin (ß-HCG)

2. Negative in women of child-bearing potential

Intra-Operative Registration/Randomization Criteria:

  • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  • A minimum of 2 or a maximum of 6 sentinel nodes are identified and excised by the surgeon. Patients who do not have an identifiable sentinel lymph node will not proceed to Registration/Randomization.
  • At least one sentinel lymph node with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+). Axillary lymph node dissection [ALND] is not to be performed prior to Registration/Randomization.

Post-Operative Registration/Randomization Criteria:

  • For cases where ALND has not been performed and one of the following is true:

1. intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive SLN with metastasis greater than 0.2 mm on hematoxylin and eosin stain (H & E) OR

2. sentinel lymph node on intra-operative evaluation considered negative was found to be positive on final pathology (with metastasis greater than 0.2 mm on H & E).

  • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
  • At least one lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H&E staining on final pathology (for cases where intra-operative evaluation was not performed, or was negative and complete dissection was not performed).
  • Among the minimum of 2 and the maximum of 6 sentinel nodes identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+).
  • For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration/randomization.

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Judy BougheyStudy Chair

Trial Sites

U.S.A.
Alaska
  Anchorage
 Alaska Breast Care and Surgery LLC
 Alison K Conlin Ph: 503-215-6412
 Alaska Women's Cancer Care
 Alison K Conlin Ph: 503-215-6412
 Anchorage Oncology Centre
 Alison K Conlin Ph: 503-215-6412
 Katmai Oncology Group
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
Arizona
  Tucson
 Arizona Cancer Center at University Medical Center North
 Michele L Ley Ph: 520-626-9008
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Michele L Ley Ph: 520-626-9008
California
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Alison K Conlin Ph: 503-215-6412
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Deborah L. Kerlin Ph: 925-674-2580
  Fresno
 California Cancer Center - Woodward Park Office
 Uzair B. Chaudhary Ph: 559-447-4050
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Armando E Giuliano Ph: 310-423-8965
 USC/Norris Comprehensive Cancer Center and Hospital
 Heather R Macdonald Ph: 323-865-0451
 Heather R Macdonald Ph: 323-865-0451
  Monterey
 Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
 John Hausdorff Ph: 831-625-4753
  Oakland
 Kaiser Permanente-Oakland
 Louis Fehrenbacher Ph: 626-564-3455
  Palo Alto
 Palo Alto Medical Foundation - Palo Alto
 Peter P. Yu Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Pasadena
 Huntington OutPatient Surgery Center
 Jeannie Shen Ph: 626-535-2420
  Redwood City
 Kaiser Permanente Medical Center - Redwood City
 Louis Fehrenbacher Ph: 626-564-3455
  Richmond
 Kaiser Permanente Medical Center - Richmond
 Louis Fehrenbacher Ph: 626-564-3455
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Louis Fehrenbacher Ph: 626-564-3455
 South Sacramento Kaiser-Permanente Medical Center
 Louis Fehrenbacher Ph: 626-564-3455
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Louis Fehrenbacher Ph: 626-564-3455
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Louis Fehrenbacher Ph: 626-564-3455
  San Leandro
 Kaiser Permanente Medical Center - Hayward
 Louis Fehrenbacher Ph: 626-564-3455
  San Rafael
 Kaiser Foundation Hospital - San Rafael
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Cruz
 Palo Alto Medical Foundation-Santa Cruz
 Peter P. Yu Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Santa Rosa
 Kaiser Permanente Medical Center - Santa Rosa
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Louis Fehrenbacher Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Frederick M Dirbas Ph: 650-498-7061
  Email: ccto-office@stanford.edu
  Stockton
 Kaiser Permanente Medical Facility - Stockton
 Louis Fehrenbacher Ph: 626-564-3455
  Sunnyvale
 Palo Atlo Medical Foundation-Sunnyvale
 Peter P. Yu Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Vacaville
 Kaiser Permanente Medical Center - Vacaville
 Louis Fehrenbacher Ph: 626-564-3455
  Vallejo
 Kaiser Permanente Medical Center - Vallejo
 Louis Fehrenbacher Ph: 626-564-3455
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Deborah L. Kerlin Ph: 925-674-2580
 Kaiser Permanente Medical Center - Walnut Creek
 Louis Fehrenbacher Ph: 626-564-3455
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Nicole Kounalakis Ph: 720-848-0650
  Colorado Springs
 Memorial Hospital Cancer Center - Colorado Springs
 Laura K Pomerenke Ph: 888-785-6789
  Fort Collins
 Poudre Valley Hospital
 Regina J Brown Ph: 970-297-6150
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Shawna C Willey Ph: 202-444-0381
 Washington Cancer Institute at Washington Hospital Center
 Shawna C Willey Ph: 202-444-0381
Florida
  Altamonte Springs
 Florida Hospital - Altamonte
 Lee M. Zehngebot Ph: 407-303-5623
  Jacksonville
 Mayo Clinic - Jacksonville
 Judy C Boughey Ph: 507-538-7623
  Kissimmee
 Florida Hospital Kissimmee
 Lee M. Zehngebot Ph: 407-303-5623
  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
 Lee M. Zehngebot Ph: 407-303-5623
 Florida Hospital East Orlando
 Lee M. Zehngebot Ph: 407-303-5623
 Florida Urology Associates-Orlando
 Lee M. Zehngebot Ph: 407-303-5623
 M.D. Anderson Cancer Center at Orlando
 Terry Mamounas Ph: 321-841-7246
  Email: CancerClinicalTrials@orlandohealth.com
  Stuart
 Robert and Carol Weissman Cancer Center at Martin Memorial
 James J. Vopal Ph: 772-288-5858ext4
 James J. Vopal Ph: 772-288-5858ext4
  Winter Park
 Florida Hospital Cancer Institute at Winter Park
 Lee M. Zehngebot Ph: 407-303-5623
Georgia
  Columbus
 John B. Amos Cancer Center
 Kenneth L Smith Ph: 706-660-6404
  Gainesville
 Northeast Georgia Medical Center
 Pierce K. Dixon Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
Hawaii
  Honolulu
 Kaiser Permanente - Moanalua Medical Center and Clinic
 Louis Fehrenbacher Ph: 626-564-3455
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
  Lewiston
 St. Joseph Regional Medical Center
 John A Keech Ph: 253-887-9333
Illinois
  Chicago
 Creticos Cancer Center at Advocate Illinois Masonic Medical Center
 Ann M. Mauer Ph: 773-296-5360
 John H. Stroger, Jr. Hospital of Cook County
 Thomas E. Lad Ph: 312-864-6000
 Mount Sinai Hospital Medical Center
 Pam G. Khosla Ph: 773-257-5960
  Email: suhi@sinai.org
 Swedish Covenant Hospital
 Elyse A Lambiase Ph: 847-316-6994
 University of Chicago Cancer Research Center
 Swati A Kulkarni Ph: 773-834-7424
  Evanston
 St. Francis Hospital
 Elyse A Lambiase Ph: 847-316-6994
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Warrenville
 Central Dupage Cancer Center
 Christy M Kesslering Ph: 630-352-5300
Indiana
  Avon
 Clarian West Medical Center
 Linda K Han Ph: 317-274-2552
  Elkhart
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Linda K Han Ph: 317-274-2552
 William N. Wishard Memorial Hospital
 Linda K Han Ph: 317-274-2552
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Robin Zon Ph: 574-234-5123
 Saint Joseph's Medical Center
 Robin Zon Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Memorial Hospital of South Bend
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Robin Zon Ph: 574-234-5123
Iowa
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Emporia
 Newman Regional Health
 Jamie L Wagner Ph: 913-588-4709
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Garden City
 St. Catherine Hospital Cancer Center
 Jamie L Wagner Ph: 913-588-4709
  Great Bend
 St. Rose Ambulatory and Surgery Center
 Jamie L Wagner Ph: 913-588-4709
  Hays
 Hays Medical Center
 Jamie L Wagner Ph: 913-588-4709
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Jamie L Wagner Ph: 913-588-4709
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Overland Park
 Kansas City Cancer Centers - Southwest
 Jamie L Wagner Ph: 913-588-4709
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pittsburg
 Mount Carmel Regional Cancer Center
 Jamie L Wagner Ph: 913-588-4709
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
 Tammy Walker Cancer Center at Salina Regional Health Center
 Jamie L Wagner Ph: 913-588-4709
  Topeka
 St. Francis Comprehensive Cancer Center
 Jamie L Wagner Ph: 913-588-4709
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Owensboro
 Mitchell Memorial Cancer Center at Owensboro Medical Health System
 Alan P Mullins Ph: 270-688-3691
  Email: shawns@omhs.org
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Ralph L Corsetti Ph: 888-562-4763
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
  Rockport
 Penobscot Bay Medical Center Cancer Care Center
 Thomas Henry Openshaw Ph: 207-973-4274
Maryland
  Towson
 Cancer Institute at St. Joseph Medical Center
 Michael J Schultz Ph: 410-337-4569
  Email: patriciajohnson@catholichealth.net
Massachusetts
  Boston
 Boston University Cancer Research Center
 Maureen T. Kavanah Ph: 617-638-8265
 Dana-Farber/Brigham and Women's Cancer Center
 Laura S Dominici Ph: 866-790-4500
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Laura S Dominici Ph: 866-790-4500
  Fitchburg
 Simonds-Sinon Regional Cancer Center at HealthAlliance Hospital - Burbank Campus
 James E. Liebmann Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
  Worcester
 UMASS Memorial Cancer Center - University Campus
 James E. Liebmann Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
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
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-4673
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-4673
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
  Niles
 Lakeland Hospital - Niles
 Robin Zon Ph: 574-234-5123
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Eric A Brown Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon Ph: 574-234-5123
  Southfield
 Providence Hospital - Southfield
 Susan E Lyons Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon Ph: 574-234-5123
  Troy
 William Beaumont Hospital - Troy Campus
 Eric A Brown Ph: 248-551-7695
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Burnsville
 Fairview Ridges Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Health Partners Inc
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Hennepin County Medical Center - Minneapolis
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Judy C Boughey Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
  Saint Louis Park
 Park Nicollet Cancer Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Bonne Terre
 Parkland Health Center-Bonne Terre
 Alan Philip Lyss Ph: 800-392-0936
  Branson
 Skaggs Cancer Center at Skaggs Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Independence
 Independence Regional Health Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Joplin
 Freeman Cancer Institute at Freeman Health System
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Kansas City Cancer Centers - North
 Jamie L Wagner Ph: 913-588-4709
 Kansas City Cancer Centers - South
 Jamie L Wagner Ph: 913-588-4709
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Lee's Summit
 Kansas City Cancer Centers - East
 Jamie L Wagner Ph: 913-588-4709
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Saint Louis
 Barnes-Jewish West County Hospital
 Amy E Cyr 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
 Mercy Clinic St. Louis Cancer and Breast Institute
 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
 Amy E Cyr Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Saint Peters
 Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
 Amy E Cyr Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Sainte Genevieve
 Sainte Genevieve County Memorial Hospital
 Alan Philip Lyss Ph: 800-392-0936
  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
  Sullivan
 Missouri Baptist Sullivan Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Sunset Hills
 Missouri Baptist Outpatient Center-Sunset Hills
 Alan Philip Lyss Ph: 800-392-0936
New Jersey
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Eric J. Miller Ph: 888-847-8823
  Paterson
 St. Joseph's Hospital and Medical Center
 Michael Maroules Ph: 973-754-2909
  Voorhees
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Eric J. Miller Ph: 888-847-8823
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 John C Russell Ph: 505-272-6972
  Las Cruces
 Memorial Medical Center
 Fa-Chyi Lee Ph: 505-272-6972
New York
  Buffalo
 Roswell Park Cancer Institute
 Ellis G. Levine Ph: 877-275-7724
  Carmel
 Putnam Hospital Center
 Gregory J Zanieski Ph: 845-483-6483
  Fishkill
 Fishkill Radiation Oncology Center
 Gregory J Zanieski Ph: 845-483-6483
  Kingston
 Ulster Radiation Oncology Center
 Gregory J Zanieski Ph: 845-483-6483
  New York
 Beth Israel Medical Center - Petrie Division
 Aye M Ma Ph: 212-523-4000
 Memorial Sloan-Kettering Cancer Center
 Tari A King Ph: 212-639-7202
 St. Luke's - Roosevelt Hospital Center - St.Luke's Division
 Aye M Ma Ph: 212-523-4000
  Poughkeepsie
 Dyson Center for Cancer Care at Vassar Brothers Medical Center
 Gregory J Zanieski Ph: 845-483-6483
  Stony Brook
 Stony Brook University Cancer Center
 Brian J O'Hea Ph: 800-862-2215
North Carolina
  Asheboro
 Randolph Hospital
 James M Granfortuna Ph: 336-832-0821
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 James M Granfortuna Ph: 336-832-0821
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Richard L. White Ph: 704-355-2884
 Pineville Radiation Therapy Center
 Richard L. White Ph: 704-355-2884
 University Radiation Oncology
 Richard L. White Ph: 704-355-2884
  Concord
 Batte Cancer Center at Northeast Medical Center
 Richard L. White Ph: 704-355-2884
  Durham
 Duke Cancer Institute
 Jeffrey Crawford Ph: 888-275-3853
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 James M Granfortuna Ph: 336-832-0821
  Hendersonville
 Park Ridge Hospital Breast Health Center
 James Dewitt Bearden Ph: 800-486-5941
  Mebane
 Cone Heath Cancer Center at Mebane
 James M Granfortuna Ph: 336-832-0821
  Monroe
 Edwards Cancer Center at Union Regional Medical Center
 Richard L. White Ph: 704-355-2884
  Reidsville
 Annie Penn Cancer Center
 James M Granfortuna Ph: 336-832-0821
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Marissa M Howard-McNatt Ph: 336-713-6771
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther H. Rehmus Ph: 330-344-6348
  Cincinnati
 Christ Hospital Cancer Center
 Jennifer B Manders Ph: 513-585-2859
 University of Cincinnati
 Elizabeth Shaughnessy Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Case Comprehensive Cancer Center
 Robert R Shenk Ph: 800-641-2422
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  West Chester
 University Pointe
 Elizabeth Shaughnessy Ph: 513-558-4553
  Email: uchealthnews@uc.edu
Oklahoma
  Oklahoma City
 Mercy Health Center
 Brian R Boggs Ph: 405-752-3388
 Oklahoma University Cancer Institute
 William C Dooley Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Victor Gerald Vogel Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Victor Gerald Vogel Ph: 570-271-5251
  Lancaster
 Lancaster General Hospital
 Daleela G Dodge Ph: 717-544-0511
  Pittsburgh
 UPMC Cancer Centers
 Gretchen M. Ahrendt Ph: 412-647-2811
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Victor Gerald Vogel Ph: 570-271-5251
South Carolina
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
  Greenville
 Bon Secours St. Francis Health System
 James Dewitt Bearden Ph: 800-486-5941
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
 Gibbs Cancer Center-Pelham
 James Dewitt Bearden Ph: 800-486-5941
  Lancaster
 Carolina Blood and Cancer Care Associates, PA
 James Dewitt Bearden Ph: 800-486-5941
  Rock Hill
 Carolina Blood and Cancer Care
 James Dewitt Bearden Ph: 800-486-5941
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Memphis
 Baptist Centers for Cancer Care
 Lindi H VanderWalde Ph: 901-226-3077
Texas
  Dallas
 Parkland Memorial Hospital
 Ann Marilyn Leitch Ph: 214-648-7097
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Ann Marilyn Leitch Ph: 214-648-7097
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Elizabeth A Mittendorf Ph: 713-792-3245
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig Ph: 888-823-5923
  Email: ctsucontact@westat.com
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Matthew M Poppe Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Virginia
  Alexandria
 INOVA Alexandria Hospital
 Costanza Cocilovo Ph: 703-208-6650
  Charlottesville
 University of Virginia Cancer Center
 Shayna L Showalter Ph: 434-243-6143
  Falls Church
 Inova Fairfax Hospital
 Costanza Cocilovo Ph: 703-208-6650
  Fredericksburg
 Hematology Oncology Associates of Fredericksburg Inc
 Harry D. Bear Ph: 804-628-1939
  Hampton
 Sentara Cancer Institute at Sentara CarePlex Hospital
 Eric C Feliberti Ph: 757-388-2406
  Midlothian
 Bon Secours Cancer Institute - Virginia Breast Center
 William J Irvin Ph: 804-594-4900
  Norfolk
 Sentara Cancer Institute at Sentara Norfolk General Hospital
 Eric C Feliberti Ph: 757-388-2406
 Sentara Leigh Hospital
 Eric C Feliberti Ph: 757-388-2406
  Richmond
 Bon Secours Cancer Institute at St. Mary's Hospital
 William J Irvin Ph: 804-594-4900
 Virginia Commonwealth University Massey Cancer Center
 Harry D. Bear Ph: 804-628-1939
  Virginia Beach
 Coastal Cancer Center at Sentara Virginia Beach General Hospital
 Eric C Feliberti Ph: 757-388-2406
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 John A Keech Ph: 253-887-9333
  Bellevue
 Overlake Cancer Center at Overlake Hospital Medical Center
 John A Keech Ph: 253-887-9333
  Centralia
 Providence Centralia Hospital
 John A Keech Ph: 253-887-9333
  Everett
 Providence Regional Cancer Partnership
 John A Keech Ph: 253-887-9333
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  Puyallup
 Good Samaritan Cancer Center
 John A Keech Ph: 253-887-9333
  Tacoma
 MultiCare Regional Cancer Center at Tacoma General Hospital
 John A Keech Ph: 253-887-9333
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Jessica F Partin Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 Anthony J. Jaslowski Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
  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
 Amanda L Kong Ph: 414-805-3666
  New Richmond
 Cancer Center of Western Wisconsin
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01901094
ClinicalTrials.gov processed this data on October 19, 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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