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Clinical Trials (PDQ®)

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

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINSABP-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

NSABP Foundation Inc

National Cancer Institute

Radiation Therapy Oncology Group

Norman Wolmark, MDPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Mobile
 University of South Alabama Mitchell Cancer Institute
 John Ronald Russell Ph: 877-904-4367
Alaska
  Anchorage
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
Arizona
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Victor J Gonzalez Ph: 520-626-9008
 Arizona Oncology - Tucson
 Vivek S Kavadi Ph: 281-277-5200
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
 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
  Orange
 St. Joseph Hospital Regional Cancer Center - Orange
 David A Margileth Ph: 714-734-6220
  Pomona
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Yallapragada S. Rao Ph: 909-865-9555
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 University of California Davis Cancer Center
 Jyoti S Mayadev Ph: 916-734-3089
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 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
 Kathleen C Horst Ph: 650-498-7061
  Email: ccto-office@stanford.edu
  Vallejo
 Sutter Solano Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
Colorado
  Aurora
 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
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Helaine F Bertsch Ph: 860-545-5363
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Neal B Goldberg Ph: 860-224-5660
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 John Louis Zapas Ph: 443-777-7364
 Washington Cancer Institute at Washington Hospital Center
 John Louis Zapas Ph: 443-777-7364
Florida
  Hollywood
 Joe DiMaggio Children's Hospital
 Srinath Sundararaman Ph: 954-265-2234
  Miami
 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
  Palatka
 Cancer Specialists of North Florida-Putnam
 Mark E Augspurger Ph: 904-202-7051
Georgia
  Atlanta
 Georgia Cancer Center for Excellence at Grady Memorial Hospital
 Mylin A Torres Ph: 404-778-1868
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
 Saint Joseph's Hospital of Atlanta
 Mylin A Torres Ph: 404-778-1868
 Winship Cancer Institute of Emory University
 Mylin A Torres Ph: 404-778-1868
 Mylin A Torres Ph: 404-778-1868
  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
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Chicago
 John H. Stroger, Jr. Hospital of Cook County
 Thomas E. Lad Ph: 312-864-6000
 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
  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 St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Warrenville
 Central Dupage Cancer Center
 Christy M Kesslering Ph: 630-352-5300
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
 Methodist Cancer Center at Methodist Hospital
 Peter A. Johnstone Ph: 317-274-2552
  South Bend
 Memorial Hospital of South Bend
 Thomas Joseph Reid Ph: 800-284-7370
Iowa
  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
  Wichita
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
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
  Baltimore
 Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
 John Louis Zapas Ph: 443-777-7364
  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
  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
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Nayana S Dekhne Ph: 248-551-7695
  Troy
 William Beaumont Hospital - Troy Campus
 Nayana S Dekhne Ph: 248-551-7695
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-4673
Minnesota
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Robert W Mutter Ph: 507-538-7623
  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 - South
 Parvesh Kumar Ph: 913-588-4709
  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
Nevada
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Michael C Hardacre Ph: 775-982-4400
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Alan C. Hartford Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  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 York
  Cooperstown
 Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
 Joy E Anderson Ph: 607-547-3073
  Email: diana.crean@bassett.org
  Poughkeepsie
 Dyson Center for Cancer Care at Vassar Brothers Medical Center
 Gregory J Zanieski Ph: 845-483-6483
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
 Blumenthal Cancer Center at Carolinas Medical Center
 Hadley J Sharp Ph: 704-355-2884
 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
  Concord
 Batte Cancer Center at Northeast Medical Center
 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
 John H Heinzerling Ph: 704-384-5369
  Matthews
 Southeast Radiation Oncology Group, PA at Matthews Radiation Oncology Center
 Justin P Favaro Ph: 704-384-5369
  Monroe
 Edwards Cancer Center at Union Regional Medical Center
 Hadley J Sharp Ph: 704-355-2884
  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
  Chardon
 Geauga Regional Hospital
 Robert R Shenk Ph: 800-641-2422
  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: 866-627-7616
  Email: osu@emergingmed.com
  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
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Robert R Shenk Ph: 800-641-2422
  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
 Oklahoma University Cancer Institute
 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
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Nimisha Deb Ph: 610-954-3582
  Email: infolink@slhn.org
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Henry Wagner 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
 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
 National Surgical Adjuvant Breast and Bowel Project
 Terry Mamounas Ph: 330-438-6281
  Email: tmamounas@aultman.com
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  York
 WellSpan Health
 Liam Eamonn Boyle Ph: 877-441-7957
South Carolina
  Charleston
 Roper St. Francis Cancer Center at Roper Hospital
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
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
  Arlington
 Texas Oncology, PA at Texas Cancer Center - Arlington South
 Vivek S Kavadi Ph: 281-277-5200
  Bedford
 Texas Oncology, PA at Harris Center HEB
 Vivek S Kavadi Ph: 281-277-5200
  Dallas
 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
  Round Rock
 Texas Oncology, PA at Texas Cancer Center Round Rock
 Vivek S Kavadi Ph: 281-277-5200
  Sugar Land
 Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
 Vivek S Kavadi Ph: 281-277-5200
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
  Email: kbodenhorn@aahs.org
  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
  Virginia Beach
 Coastal Cancer Center at Sentara Virginia Beach General Hospital
 Mark E Shaves Ph: 757-388-2406
Washington
  Bremerton
 Harrison Medical Center
 Tanya Austin Wahl Ph: 425-688-5407
  Email: patra.grevstad@swedish.org
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 Janice N Kim Ph: 800-804-8824
  Puyallup
 Good Samaritan Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  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
 Yoshio Inoue Ph: 253-403-2394
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
  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
  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
  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
  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
Canada
Alberta
  Edmonton
 Cross Cancer Institute at University of Alberta
 Keith Tankel Ph: 780-432-8500
Quebec
  Montreal
 Jewish General Hospital - Montreal
 Richard G. Margolese Ph: 514-340-8222ext8248
 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 Identifer NCT01872975
ClinicalTrials.gov processed this data on November 12, 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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