Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherNSABP-B-51/RTOG-1304
NCI-2012-03198, U10CA012027, NCT01872975

Trial Description

Summary

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Further Study Information

PRIMARY OBJECTIVES:

To evaluate whether the addition of chest wall + regional nodal radiation therapy (XRT) after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly prolong overall survival (OS) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

II. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rates of events for local-regional recurrence-free interval (LRRFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

III. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for distant recurrence-free interval (DRFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

IV. To compare the rates of disease-free survival (DFS)-ductal carcinoma in situ (DCIS) by treatment arm.

V. To compare the rates of second primary cancer (SPC) by treatment arm.

VI. To compare the effect of adding XRT on the cosmetic outcomes in mastectomy patients who have had reconstruction.

VII. To compare the effect of adding XRT on quality of life including arm problems, lymphedema, pain, and fatigue.

VIII. To evaluate the toxicity associated with each of the radiation therapy regimens.

IX. To determine whether computed tomography (CT)-based conformal methods (intensity-modulated radiation therapy [IMRT] and 3-dimensional conformal radiation therapy [3DCRT]) for chestwall + regional nodal XRT post mastectomy and regional nodal XRT with breast XRT following breast conserving surgery are feasible in a multi-institutional setting and whether dose-volume analyses can be established to assess treatment adequacy and to develop normal tissue complication probabilities (NTCP) for the likelihood of toxicity.

X. To compare the effect of XRT in patients receiving mastectomy and in patients receiving lumpectomy.

XI. To examine the role of proliferation measures as a prognosticator for patients with residual disease after neoadjuvant chemotherapy.

XII. To develop predictors of the degree of reduction in local regional recurrence (LRR).

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

ARM 1: Patients are assigned to 1 of 2 treatment groups.

GROUP 1A: Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.

GROUP 1B: Mastectomy patients do not undergo radiation therapy.

ARM 2: Patients are assigned to 1 of 2 treatment groups.

GROUP 2A: Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.

GROUP 2B: Mastectomy patients undergo regional nodal radiation therapy and chestwall XRT using IMRT or 3DCRT once daily 5 days a week for 5 weeks.

All patients also receive systemic therapy as planned (hormonal therapy for patients with hormone-receptor positive breast cancer and trastuzumab or other anti-human epidermal growth factor receptor 2 [HER2] therapy for patients with breast cancer that is HER2-positive).

After completion of study treatment, patients are followed up at 6, 12, 18, and 24 months and then yearly for 8 years.

Eligibility Criteria

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan
  • Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
  • Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org)
  • Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.org); patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible
  • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
  • For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting
  • Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
  • At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:
  • Axillary node dissection
  • Sentinel node biopsy alone or
  • Sentinel node biopsy followed by axillary node dissection
  • Note: Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an NCI Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study
  • Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible (Note: Postneoadjuvant therapy is designated with a "yp" prefix.)
  • Patient who have undergone either a total mastectomy or a lumpectomy are eligible
  • For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
  • For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor
  • The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 56 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 56 days
  • The patient must have recovered from surgery with the incision completely healed and no signs of infection
  • If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease
  • T4 tumors including inflammatory breast cancer
  • Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
  • N2 or N3 disease detected clinically or by imaging
  • Patients with histologically positive axillary nodes post neoadjuvant therapy
  • Patients with microscopic positive margins after definitive surgery
  • Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)
  • Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
  • Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
  • Prior breast or thoracic radiation therapy (RT) for any condition
  • Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
  • Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

Trial Contact Information

Trial Lead Organizations/Sponsors

National Surgical Adjuvant Breast and Bowel Project

  • National Cancer Institute
  • Radiation Therapy Oncology Group
Norman Wolmark, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

UAB Comprehensive Cancer Center

Jennifer F De Los Santos
Ph: 205-934-0309

Mobile

University of South Alabama Mitchell Cancer Institute

John Ronald Russell
Ph: 877-904-4367
Email: pfrancisco@usouthal.edu

Alaska
Anchorage

Providence Cancer Center

Alison K Conlin
Ph: 503-215-6412

Arizona
Tucson

Arizona Oncology - Tucson

Vivek S Kavadi
Ph: 281-277-5200

Arkansas
Little Rock

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Matthew E Hardee
Ph: 501-686-8274

California
Duarte

City of Hope Comprehensive Cancer Center

Lily L. Lai
Ph: 800-826-4673
Email: becomingapatient@coh.org

Fresno

California Cancer Center - Woodward Park Office

Uma G Swamy
Ph: 559-447-4050

Los Angeles

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Christiane M Burnison
Ph: 310-423-8965

USC/Norris Comprehensive Cancer Center and Hospital

Eugene I Chung
Ph: 323-865-0451

Eugene I Chung
Ph: 323-865-0451

Oakland

Alta Bates Summit Medical Center - Summit Campus

James H. Feusner
Ph: 510-450-7600

Kaiser Permanente-Oakland

Louis Fehrenbacher
Ph: 626-564-3455

Orange

St. Joseph Hospital Regional Cancer Center - Orange

David A Margileth
Ph: 714-734-6220

Palo Alto

Stanford Cancer Center

Kathleen C Horst
Ph: 650-498-7061
Email: ccto-office@stanford.edu

Pasadena

Huntington OutPatient Surgery Center

Ruth C Williamson
Ph: 626-535-2420

Pomona

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Yallapragada S. Rao
Ph: 909-865-9555

Rohnert Park

Rohnert Park Cancer Center

Louis Fehrenbacher
Ph: 626-564-3455

Roseville

Kaiser Permanente Medical Center - Roseville

Louis Fehrenbacher
Ph: 626-564-3455

Sutter Cancer Center at Roseville Medical Center

Stacy D D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

The Permanente Medical Group-Roseville Radiation Oncology

Louis Fehrenbacher
Ph: 626-564-3455

Sacramento

Sutter Cancer Center

Stacy D D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

University of California Davis Cancer Center

Jyoti S Mayadev
Ph: 916-734-3089

Saint Helena

Saint Helena Hospital

Gregory B Smith
Ph: 707-967-3698

Santa Clara

Kaiser Permanente Medical Center - Santa Clara Homestead Campus

Louis Fehrenbacher
Ph: 626-564-3455

South Pasadena

City of Hope Medical Group, Incorporated

Lily L. Lai
Ph: 800-826-4673
Email: becomingapatient@coh.org

South San Francisco

Kaiser Permanente Medical Center - South San Francisco

Louis Fehrenbacher
Ph: 626-564-3455

Vallejo

Sutter Solano Medical Center

Stacy D D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Colorado
Aurora

Rocky Mountain Cancer Centers - Aurora

Keren Sturtz
Ph: 888-785-6789

University of Colorado Cancer Center at UC Health Sciences Center

Rachel A. Rabinovitch
Ph: 720-848-0650

Boulder

Rocky Mountain Cancer Centers-Boulder

Keren Sturtz
Ph: 888-785-6789

Colorado Springs

Memorial Hospital Cancer Center - Colorado Springs

Rachel A. Rabinovitch
Ph: 720-848-0650

Penrose Cancer Center at Penrose Hospital

Keren Sturtz
Ph: 888-785-6789

Denver

Porter Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Fort Collins

Poudre Valley Hospital

Rachel A. Rabinovitch
Ph: 720-848-0650

Littleton

Rocky Mountain Cancer Centers - Littleton

Keren Sturtz
Ph: 888-785-6789

Thornton

Rocky Mountain Cancer Centers - Thornton

Keren Sturtz
Ph: 888-785-6789

Wheat Ridge

Exempla Lutheran Medical Center

Keren Sturtz
Ph: 888-785-6789

Connecticut
New Britain

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

Neal B Goldberg
Ph: 860-224-5660

District of Columbia
Washington

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Edward C McCarron
Ph: 443-777-7364

Sibley Memorial Hospital

Jean L Wright
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Washington Cancer Institute at Washington Hospital Center

Edward C McCarron
Ph: 443-777-7364

Florida
Atlantis

JFK Medical Center

Beth-Ann Lesnikoski
Ph: 888-823-5923
Email: ctsucontact@westat.com

Deerfield Beach

University of Miami/Deerfield Beach

Cristiane Takita
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Gainesville

UF Health Cancer Center

Judith L Lightsey
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

Hollywood

Joe DiMaggio Children's Hospital

Srinath Sundararaman
Ph: 954-265-2234

Miami

Jackson Memorial Hospital

Cristiane Takita
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

University of Miami Sylvester Comprehensive Cancer Center - Miami

Cristiane Takita
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Orlando

Florida Hospital Cancer Institute at Florida Hospital Orlando

Carlos A Alemany
Ph: 407-303-5623

M.D. Anderson Cancer Center at Orlando

Tomas Dvorak
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Georgia
Atlanta

Piedmont Hospital

Adam W Nowlan
Ph: 404-425-7943
Email: ORS@piedmont.org

Carrollton

Tanner Medical Center/Carrollton

James R Bland
Ph: 770-836-9824

Decatur

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Jayanthi Srinivasiah
Ph: 404-501-3279

Savannah

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

Harvey C. Lebos
Ph: 912-350-8568

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

John A Pablo
Ph: 800-622-6877

Hawaii
Ewa Beach

Leeward Radiation Oncology

Kenneth N Sumida
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Honolulu

Hawaii Medical Center - East

Kenneth N Sumida
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Queen's Cancer Institute at Queen's Medical Center

Kenneth N Sumida
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Samir Narayan
Ph: 734-712-4673

Illinois
Chicago

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

University of Chicago Cancer Research Center

Steven J Chmura
Ph: 773-834-7424

Maywood

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Tarita O Thomas
Ph: 708-226-4357

Naperville

Edward Hospital Cancer Center

Vasudha Lingareddy
Ph: 630-646-6075

New Lennox

Silver Cross Hospital

Steven J Chmura
Ph: 773-834-7424

Park Ridge

Advocate Lutheran General Cancer Care Center

Jacob D. Bitran
Ph: 847-384-3621

Peoria

Illinois CancerCare - Peoria

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

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

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

OSF St. Francis Medical Center

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

Indiana
Goshen

Center for Cancer Care at Goshen General Hospital

Laura L. Morris
Ph: 574-535-2858

Indianapolis

Community Regional Cancer Care at Community Hospital East

Shih J Wei
Ph: 317-621-7104

Community Regional Cancer Care at Community Hospital North

Shih J Wei
Ph: 317-621-7104

Indiana University Melvin and Bren Simon Cancer Center

Mark P Langer
Ph: 317-274-2552

South Bend

Memorial Hospital of South Bend

Thomas Joseph Reid
Ph: 800-284-7370

Iowa
Clive

Mercy Cancer Center - West Lakes

Mehmet S. Copur
Ph: 800-998-2119

Des Moines

John Stoddard Cancer Center at Iowa Methodist Medical Center

Robert J Behrens
Ph: 515-282-2921

Mercy Cancer Center at Mercy Medical Center - Des Moines

Mehmet S. Copur
Ph: 800-998-2119

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Alexandra Thomas
Ph: 800-237-1225

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

Kentucky
Louisville

Baptist Hospital East - Louisville

James B Eckman
Ph: 502-897-8592
Email: Cbcresearch@bhsi.com

University of Louisville School of Medicine

Anthony E Dragun
Ph: 866-530-5516

Louisiana
New Orleans

Ochsner Cancer Institute at Ochsner Clinic Foundation

Mini J Elnaggar
Ph: 888-562-4763

Maine
Bangor

CancerCare of Maine at Eastern Maine Medical Center

Thomas Henry Openshaw
Ph: 207-973-4274

Maryland
Annapolis

DeCesaris Cancer Institute at Anne Arundel Medical Center

Mary E Young
Ph: 443-481-1320
Email: kbodenhorn@aahs.org

Baltimore

Greenebaum Cancer Center at University of Maryland Medical Center

Steven Feigenberg
Ph: 800-888-8823

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Edward C McCarron
Ph: 443-777-7364

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Jean L Wright
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Columbia

Central Maryland Oncology Center

Steven Feigenberg
Ph: 800-888-8823

Glen Burnie

Tate Cancer Center at Baltimore Washington Medical Center

Steven Feigenberg
Ph: 800-888-8823

Massachusetts
Boston

Boston University Cancer Research Center

Ariel E Hirsch
Ph: 617-638-8265

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Faina Nakhlis
Ph: 617-983-7000

Lowell

Lowell General Hospital

Matthew S Katz
Ph: 978-788-7084
Email: ghincks@lowellgeneral.org

Michigan
Ann Arbor

University of Michigan Comprehensive Cancer Center

Lori J. Pierce
Ph: 800-865-1125

Clinton Township

Henry Ford Macomb Hospital

Thomas Joseph Doyle
Ph: 313-916-1784

Detroit

Josephine Ford Cancer Center at Henry Ford Hospital

Thomas Joseph Doyle
Ph: 313-916-1784

Van Elslander Cancer Center at St. John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Grand Rapids

Butterworth Hospital at Spectrum Health

Gilbert D Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Muskegon

Mercy General Health Partners

Gilbert D Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Pontiac

St. Joseph Mercy Oakland

Samir Narayan
Ph: 734-712-4673

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Nayana S Dekhne
Ph: 248-551-7695

Trenton

Down River Center for Oncology

Thomas Joseph Doyle
Ph: 313-916-1784

Troy

William Beaumont Hospital - Troy Campus

Nayana S Dekhne
Ph: 248-551-7695

Warren

St. John Macomb Hospital

Samir Narayan
Ph: 734-712-4673

West Bloomfield

Henry Ford Medical Center - West Bloomfield

Thomas Joseph Doyle
Ph: 313-916-1784

Minnesota
Fridley

Mercy and Unity Cancer Center at Unity Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Mankato

Immanuel St. Joseph's

Ron S. Smith
Ph: 507-385-2929

Minneapolis

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Saint Cloud

CentraCare Clinic - Women and Children

Barbi L. Kaplan-Frenkel
Ph: 877-229-4907
Email: coborncancercenter@centracare.com

Saint Paul

United Hospital

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Waconia

Ridgeview Medical Center

Patrick J. Flynn
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Missouri
Kansas City

Kansas City Cancer Centers - North

Parvesh Kumar
Ph: 913-588-4709

Kansas City Cancer Centers - South

Parvesh Kumar
Ph: 913-588-4709

North Kansas City Hospital

Parvesh Kumar
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

Parvesh Kumar
Ph: 913-588-4709

Saint Louis

Barnes-Jewish West County Hospital

Maria A Thomas
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Maria A Thomas
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Saint Peters

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

Maria A Thomas
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Montana
Kalispell

Kalispell Regional Medical Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Nebraska
Grand Island

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

Mehmet S. Copur
Ph: 800-998-2119

Omaha

Lakeside Hospital

Mehmet S. Copur
Ph: 800-998-2119

Nevada
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

Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Alan C. Hartford
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

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

Beryl McCormick
Ph: 212-639-7202

Livingston

St. Barnabas Medical Center Cancer Center

Alison Grann
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

New Brunswick

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Atif J Khan
Ph: 732-235-8675

Ridgewood

Valley Hospital - Ridgewood

Laura A Klein
Ph: 201-634-5792

Sparta

Frederick R. and Betty M. Smith Cancer Treatment Center

Pramila Rani Anne
Ph: 215-955-6084

Voorhees

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Lemuel S. Ariaratnam
Ph: 888-847-8823

New Mexico
Albuquerque

University of New Mexico Cancer Center

Benny J. Liem
Ph: 505-272-6972

New York
Commack

Memorial Sloan-Kettering Cancer Center

Beryl McCormick
Ph: 212-639-7202

Cooperstown

Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

Joy E Anderson
Ph: 607-547-3073
Email: diana.crean@bassett.org

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Eileen P Connolly
Ph: 212-305-8615

Memorial Sloan-Kettering Cancer Center

Beryl McCormick
Ph: 212-639-7202

Poughkeepsie

Dyson Center for Cancer Care at Vassar Brothers Medical Center

Gregory J Zanieski
Ph: 845-483-6483

Rockville Centre

Memorial Sloan-Kettering Cancer Center - Rockville Centre

Beryl McCormick
Ph: 212-639-7202

Sleepy Hollow

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Beryl McCormick
Ph: 212-639-7202

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Beryl McCormick
Ph: 212-639-7202

North Carolina
Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Timothy M Zagar
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Charlotte

Pineville Radiation Therapy Center

Hadley J Sharp
Ph: 704-355-2884

Presbyterian Cancer Center at Presbyterian Hospital

Justin P Favaro
Ph: 704-384-5369

University Radiation Oncology

Hadley J Sharp
Ph: 704-355-2884

Durham

Duke Cancer Institute

Rachel C Blitzblau
Ph: 888-275-3853

Gastonia

CaroMont Cancer Center at Gaston Memorial Hospital

Charles J. Meakin
Ph: 704-834-2932

Greensboro

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

James M Granfortuna
Ph: 336-832-0821

Greenville

Leo W. Jenkins Cancer Center at ECU Medical School

Eleanor E.R. Harris
Ph: 252-744-2391

Matthews

Southeast Radiation Oncology Group, PA at Matthews Radiation Oncology Center

Justin P Favaro
Ph: 704-384-5369

Supply

South Atlantic Radiation Oncology, LLC

Michael A Papagikos
Ph: 910-251-1839

Wilmington

Coastal Carolina Radiation Oncology Center

Michael A Papagikos
Ph: 910-251-1839

North Dakota
Bismarck

Medcenter One Hospital Cancer Care Center

Preston D. Steen
Ph: 701-234-6161

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Andrew H. Fenton
Ph: 330-344-6348

Summa Center for Cancer Care at Akron City Hospital

Jennifer E Payne
Ph: 330-375-6101

Barberton

Barberton Citizens Hospital

Jennifer E Payne
Ph: 330-375-6101

Beachwood

UHHS Chagrin Highlands Medical Center

Robert R Shenk
Ph: 800-641-2422

Canton

Aultman Cancer Center at Aultman Hospital

Shruti Trehan
Ph: 330-363-6891

Chardon

Geauga Regional Hospital

Robert R Shenk
Ph: 800-641-2422

Cincinnati

Bethesda North Hospital

Ching Ho
Ph: 513-862-2230

Good Samaritan Hospital Cancer Treatment Center

Ching Ho
Ph: 513-862-2230

Cleveland

Case Comprehensive Cancer Center

Robert R Shenk
Ph: 800-641-2422

Cleveland Clinic Cancer Center at Fairview Hospital

Rahul D Tendulkar
Ph: 866-223-8100

Cleveland Clinic Taussig Cancer Center

Rahul D Tendulkar
Ph: 866-223-8100

Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Julia R. White
Ph: 800-293-5066
Email: Jamesline@osumc.edu

Zangmeister Center

J. Philip Kuebler
Ph: 614-566-3275

Delaware

Delaware Radiation Oncology

J. Philip Kuebler
Ph: 614-566-3275

Independence

Cleveland Clinic Taussig Cancer Center

Rahul D Tendulkar
Ph: 866-223-8100

Mayfield Heights

Hillcrest Cancer Center at Hillcrest Hospital

Rahul D Tendulkar
Ph: 866-223-8100

Medina

Summa Health Center at Lake Medina

Jennifer E Payne
Ph: 330-375-6101

Mentor

Lake/University Ireland Cancer Center

Robert R Shenk
Ph: 800-641-2422

Middleburg Heights

Southwest General Health Center

Robert R Shenk
Ph: 800-641-2422

Sandusky

North Coast Cancer Care, Incorporated

Rahul D Tendulkar
Ph: 866-223-8100

Strongsville

Cleveland Clinic Foundation - Strongsville

Rahul D Tendulkar
Ph: 866-223-8100

Westlake

UHHS Westlake Medical Center

Robert R Shenk
Ph: 800-641-2422

Wooster

Cleveland Clinic - Wooster

Rahul D Tendulkar
Ph: 866-223-8100

Oklahoma
Lawton

Cancer Centers of Southwest Oklahoma, LLC - Lawton

Nadim F. Nimeh
Ph: 877-231-4440

Oklahoma City

Mercy Health Center

Astrid E Morrison
Ph: 405-751-4343

Stephenson Cancer Center at the University of Oklahoma

Terence S. Herman
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Oregon
Gresham

Legacy Mount Hood Medical Center

Jay C Andersen
Ph: 800-220-4937

Pennsylvania
Allentown

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Alyson F McIntosh
Ph: 610-402-2273

Beaver

UPMC Cancer Center at Beaver Medical Center

Sushil Beriwal
Ph: 412-647-2811

Bethlehem

St. Luke's Cancer Network at St. Luke's Hospital

Nimisha Deb
Ph: 610-954-3582
Email: infolink@slhn.org

Dunmore

Northeast Radiation Oncology Center

Pramila Rani Anne
Ph: 215-955-6084

Erie

Regional Cancer Center - Erie

Andrew T Figura
Ph: 814-838-0448
Email: mhaynes@trcc.org

Furlong

Fox Chase Cancer Center Buckingham

Penny R Anderson
Ph: 215-728-4790

Gettysburg

Adams Cancer Center

Liam Eamonn Boyle
Ph: 877-441-7957

Harrisburg

PinnacleHealth Regional Cancer Center at Polyclinic Hospital

Brij M Sood
Ph: 717-724-6765
Email: klitchfield@PINNACLEHEALTH.org

Hershey

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Jennifer C Rosenberg
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

Lancaster

Lancaster General Hospital

Jeffery S Eshleman
Ph: 717-544-5511

Monroeville

Intercommunity Cancer Center

Thomas B Julian
Ph: 877-284-2000

Natrona Heights

Alle-Kiski Medical Center

Thomas B Julian
Ph: 877-284-2000

Philadelphia

Fox Chase Cancer Center - Philadelphia

Penny R Anderson
Ph: 215-728-4790

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Pramila Rani Anne
Ph: 215-955-6084

Pittsburgh

Allegheny Cancer Center at Allegheny General Hospital

Thomas B Julian
Ph: 877-284-2000

UPMC - Shadyside

Sushil Beriwal
Ph: 412-647-2811

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Terrence P. Cescon
Ph: 610-988-9323

Wexford

Allegheny Health Network

Thomas B Julian
Ph: 877-284-2000

York

WellSpan Health

Liam Eamonn Boyle
Ph: 877-441-7957

South Carolina
Charleston

Hollings Cancer Center at Medical University of South Carolina

Jennifer L Harper
Ph: 843-792-9321

Roper St. Francis Cancer Center at Roper Hospital

James Michael Orcutt
Ph: 843-720-8386
Email: elizabeth.strojny@roperstfrancis.com

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

Gibbs Cancer Center-Pelham

Steven W Corso
Ph: 800-486-5941

Seneca

Cancer Centers of the Carolinas - Seneca

David L Grisell
Ph: 864-241-6251

Spartanburg

Cancer Centers of the Carolinas - Spartanburg

David L Grisell
Ph: 864-241-6251

South Dakota
Sioux Falls

Avera Cancer Institute

Addison R Tolentino
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Tennessee
Knoxville

Thompson Cancer Survival Center

Daniel D Scaperoth
Ph: 865-541-1812

Texas
Austin

Texas Oncology - Midtown Austin

Vivek S Kavadi
Ph: 281-277-5200

Texas Oncology, PA at South Austin Cancer Center

Vivek S Kavadi
Ph: 281-277-5200

Texas Oncology, PA at Texas Oncology Cancer Center - Central

Vivek S Kavadi
Ph: 281-277-5200

Bedford

Texas Oncology, PA at Harris Center HEB

Vivek S Kavadi
Ph: 281-277-5200

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

Fort Worth

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

Vivek S Kavadi
Ph: 281-277-5200

Houston

Memorial Hermann Hospital - Memorial City

Vivek S Kavadi
Ph: 281-277-5200

Univeristy of Texas M.D. Anderson Cancer Center

Simona F Shaitelman
Ph: 713-792-3245

Laredo

Doctor's Hospital of Laredo

Gary W. Unzeitig
Ph: 888-823-5923
Email: ctsucontact@westat.com

Lubbock

Covenant Medical Center

Ibrahim A Shalaby
Ph: 806-725-8000
Email: jaccresearch@covhs.org

Plano

Texas Oncology - Plano West Cancer Center

Vivek S Kavadi
Ph: 281-277-5200

Round Rock

Texas Oncology, PA at Texas Cancer Center Round Rock

Vivek S Kavadi
Ph: 281-277-5200

San Antonio

University of Texas Health Science Center at San Antonio

Richard L Crownover
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Sugar Land

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

Vivek S Kavadi
Ph: 281-277-5200

Utah
Murray

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Vilija N Avizonis
Ph: 801-507-3950

Salt Lake City

Huntsman Cancer Institute at University of Utah

Matthew M Poppe
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Vermont
Saint Johnsbury

Norris Cotton Cancer Center - North

Alan C. Hartford
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Virginia
Alexandria

INOVA Alexandria Hospital

Jane Grayson
Ph: 703-776-2580
Email: research@inova.org

Charlottesville

University of Virginia Cancer Center

Shayna L Showalter
Ph: 434-243-6143

Falls Church

Inova Fairfax Hospital

Ashish K Chawla
Ph: 703-208-6650

Hampton

Sentara Cancer Institute at Sentara CarePlex Hospital

Mark E Shaves
Ph: 757-388-2406

Norfolk

Sentara Cancer Institute at Sentara Norfolk General Hospital

Mark E Shaves
Ph: 757-388-2406

Richmond

Virginia Commonwealth University Massey Cancer Center

Harry D. Bear
Ph: 804-628-1939

Roanoke

Blue Ridge Cancer Care - Roanoke

Toby C Campbell
Ph: 877-405-6866

Virginia Beach

Coastal Cancer Center at Sentara Virginia Beach General Hospital

Mark E Shaves
Ph: 757-388-2406

Washington
Bellevue

Overlake Cancer Center at Overlake Hospital Medical Center

John A Keech
Ph: 907-458-5380

Bremerton

Harrison Medical Center

Tanya Austin Wahl
Email: patra.grevstad@swedish.org

Gig Harbor

Tacoma/Valley Radiation Oncology Centers-Gig Harbor

John A Keech
Ph: 907-458-5380

Mount Vernon

Skagit Valley Hospital Cancer Care Center

Janice N Kim
Ph: 800-804-8824

Puyallup

Good Samaritan Cancer Center

John A Keech
Ph: 907-458-5380

Takoma/Valley Radiation Oncology Center at Good Samaritan

John A Keech
Ph: 907-458-5380

Seattle

Seattle Cancer Care Alliance

Janice N Kim
Ph: 800-804-8824

Spokane

Cancer Care Northwest - Spokane South

Janice N Kim
Ph: 800-804-8824

Tacoma

MultiCare Regional Cancer Center at Tacoma General Hospital

John A Keech
Ph: 907-458-5380

Northwest Medical Specialties, PLLC - Tacoma

Mehmet S. Copur
Ph: 800-998-2119

Tacoma/Valley Radiation Oncology Center - St. Joseph

John A Keech
Ph: 907-458-5380

Vancouver

Northwest Cancer Specialists at Vancouver Cancer Center

Vivek S Kavadi
Ph: 281-277-5200

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
Appleton

Fox Valley Surgical Associates at Appleton Medical Center

Editha (Edie) A Krueger
Ph: 920-380-1500

Honnie R Bermas
Ph: 800-574-3872

Eau Claire

Center for Cancer Treatment & Prevention at Sacred Heart Hospital

Jessica A Wernberg
Ph: 715-389-4457

Grafton

Aurora Cancer Care-Grafton

Mitchell H. Pincus
Ph: 800-252-2990

Green Bay

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

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

Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Bethany M Anderson
Ph: 877-405-6866

Marshfield

Saint Joseph's Hospital

Jessica A Wernberg
Ph: 715-389-4457

Menomonee Falls

Community Memorial Hospital Cancer Care Center

Adam D Currey
Ph: 414-805-4380

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Adam D Currey
Ph: 414-805-4380

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Mitchell H. Pincus
Ph: 800-252-2990

Minocqua

Marshfield Clinic - Lakeland Center

Jessica A Wernberg
Ph: 715-389-4457

Neenah

Surgical Associates of Neenah, SC

Editha (Edie) A Krueger
Ph: 920-380-1500

Oconomowoc

Regional Cancer Center at Oconomowoc Memorial Hospital

Wingate F. Clapper
Ph: 262-928-7632

Rice Lake

Marshfield Clinic - Indianhead Center

Jessica A Wernberg
Ph: 715-389-4457

Stevens Point

Saint Michael's Hospital Cancer Center

Jessica A Wernberg
Ph: 715-389-4457

Summit

Aurora Medical Center

Mitchell H. Pincus
Ph: 800-252-2990

Two Rivers

Vince Lombardi Cancer Clinic - Two Rivers

Mitchell H. Pincus
Ph: 800-252-2990

Waukesha

Waukesha Memorial Hospital Regional Cancer Center

Wingate F. Clapper
Ph: 262-928-7632

Wauwatosa

Oncology Alliance, SC - Milwaukee - West

Mitchell H. Pincus
Ph: 800-252-2990

West Allis

Aurora Women's Pavilion of West Allis Memorial Hospital

Mitchell H. Pincus
Ph: 800-252-2990

West Bend

Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital

Adam D Currey
Ph: 414-805-4380

Canada

Alberta
Calgary

Tom Baker Cancer Centre - Calgary

Keith Tankel
Ph: 780-432-8500

Edmonton

Cross Cancer Institute at University of Alberta

Keith Tankel
Ph: 780-432-8500

Quebec
Montreal

Jewish General Hospital - Montreal

Thierry M Muanza
Ph: 514-398-1444
Email: penny.chipman@mcgill.ca

Maisonneuve-Rosemont Hospital

Michael Yassa
Ph: 514-252-3400ext3329

Quebec City

Centre Hospitalier Universitaire de Quebec

Valerie Theberge
Ph: 418-525-4444

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01872975
ClinicalTrials.gov processed this data on May 07, 2015

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