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Clinical Trials (PDQ®)

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive40 and overNCI, OtherCDR0000728605
ACOSOG-Z11102, Z11102, NCT01556243

Trial Description

Summary

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

Further Study Information

OBJECTIVES:

Primary

  • To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).

Secondary

  • To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.
  • To assess whether patients who did not undergo re-excision for close margins (< 2 mm) have a higher local recurrence (LR) rate than patients for whom negative margins were achieved.
  • To assess patient's perception of cosmesis and incidence of breast lymphedema.
  • To examine the type and severity of adverse effects of BCS and radiation for women with MIBC.
  • To assess incidence of breast lymphedema
  • To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.

OUTLINE: This is a multicenter study.

Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.

Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole-breast irradiation (WBI) with a boost to the lumpectomy bed of each site of disease 5 days a week for approximately 6 weeks at the discretion of the surgeon.

Patients complete the Breast-Conserving Therapy Module (BREAST-Q© subscales) questionnaire 5-30 days after surgery and every 6 months for the first 2 years and the yearly for the next 3 years after WBI. Patients' surgeons also complete the questionnaire 5-30 days after performing final surgery to assess cosmetic outcomes.

After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly for years 3-5.

Eligibility Criteria

Registration Inclusion Criteria:

1. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.

2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)

3. Female Gender - Men are excluded from this study. Male breast cancer is a rare event.

Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

4. Foci of Breast Cancer - Upon clinical exam and pre-operative imaging by both MRI and mammogram, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue. Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).

No more than 2 quadrants with biopsy proven breast cancer.

Note: Patient is eligible for study if lesion is not visualized on both imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI). Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only. Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.

5. Mammogram Imaging - Bilateral mammogram ≤ 60 days prior to registration

6. MRI Imaging - Bilateral breast MRI ≤ 60 days prior to registration

7. Staging of Cancer - cN0 or cN1 disease

8. ECOG Performance Status (PS) - 0, 1, or 2.

Note: An ECOG PS scale is available on the Cancer Trial Support Unit (CTSU) website.

9. Hemoglobin and Platelet Count - The following laboratory values obtained ≤ 21 days prior to registration:

  • Hemoglobin (Hgb) ≥ 8 g/dL
  • Peripheral platelet count (PLT) ≥ 50,000/mm3

10. Pregnancy for Women of Childbearing Potential - Negative urine or serum pregnancy test result ≤ 7 days prior to registration for women of childbearing potential only.

11. Ability to Complete Questionnaires by themselves or with assistance.

12. Ability to Provide Written Informed Consent

13. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution.

Registration Exclusion Criteria:

1. Pregnancy, Nursing and Requirement for Contraception Any of the following because this study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects:

  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)

2. Size of Single Focus of Disease - Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1centimeter of the index lesion.

3. Prior Staging Procedure - Surgical axillary staging procedure prior to study entry.

Note: FNA or core needle biopsy of axillary node is permitted.

4. Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease

5. Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]

6. Staging of Cancer - cNX, cN2, or cN3 disease

7. Breast Implants at time of diagnosis.

Note: Patients who have had implants previously removed prior to diagnosis are eligible.

8. Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).

9. Uncontrolled Intercurrent Illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

10. Bilateral Breast Cancer Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).

11. Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to registration.

12. Chemotherapy or Endocrine Therapy Prior to Surgery - Neoadjuvant chemotherapy or neoadjuvant endocrine therapy (in other words, no chemotherapy or endocrine therapy prior to surgery) for this cancer.

13. Partial Breast Radiation - Planned partial breast radiation.

14. Investigational Agents - Administration of any investigational agent ≤ 30 days prior to registration.

15. Known BRCA Mutations - Patients with known BRCA mutations.

16. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Judy BougheyStudy Chair

Trial Sites

U.S.A.
California
  Dublin
 Epic Care-Dublin
 James H. Feusner Ph: 510-450-7600
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Sarah L Blair Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Armando E Giuliano Ph: 310-423-8965
  Martinez
 Contra Costa Regional Medical Center
 James H. Feusner Ph: 510-450-7600
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 James H. Feusner Ph: 510-450-7600
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
 Epic Care - Oakland
 James H. Feusner Ph: 510-450-7600
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 James H. Feusner Ph: 510-450-7600
  San Diego
 Naval Medical Center - San Diego
 Tawakalitu O Oseni Ph: 619-532-8712
  Stanford
 Stanford Cancer Center
 Frederick M Dirbas Ph: 650-498-7061
  Email: ccto-office@stanford.edu
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Nicole Kounalakis Ph: 720-848-0650
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Tari S Stull Ph: 734-712-4673
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Diana Dickson-Witmer Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Diana Dickson-Witmer Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Diana Dickson-Witmer Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Diana Dickson-Witmer Ph: 302-733-6227
 Diana Dickson-Witmer Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Diana Dickson-Witmer Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Diana Dickson-Witmer Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Diana Dickson-Witmer Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Diana Dickson-Witmer Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Diana Dickson-Witmer Ph: 302-733-6227
District of Columbia
  Washington
 Washington Cancer Institute at Washington Hospital Center
 Bridget A Oppong Ph: 202-444-0381
Florida
  Clearwater
 Morton Plant Hospital
 Peter William Blumencranz Ph: 727-461-8519
  Deerfield Beach
 University of Miami/Deerfield Beach
 Eli Avisar Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Eli Avisar Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
Georgia
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Howard A. Zaren Ph: 800-622-6877
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Ewa Beach
 Leeward Radiation Oncology
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 Hawaii Medical Center - East
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kapiolani Medical Center for Women and Children
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kuakini Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Tari S Stull Ph: 734-712-4673
Illinois
  Chicago
 Resurrection Medical Center
 Christopher G. Rose Ph: 773-792-5116
 University of Illinois Cancer Center
 Alejandra M Perez-Tamayo Ph: 312-567-2600
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
Indiana
  Avon
 Clarian West Medical Center
 Linda K Han Ph: 317-274-2552
  Carmel
 IU Health North Hospital
 Linda K Han Ph: 317-274-2552
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Fishers
 Central Indiana Cancer Centers - North
 Linda K Han Ph: 317-274-2552
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Linda K Han Ph: 317-274-2552
 Methodist Cancer Center at Methodist Hospital
 Linda K Han Ph: 317-274-2552
 William N. Wishard Memorial Hospital
 Linda K Han Ph: 317-274-2552
  Mishawaka
 Memorial Regional Cancer Center Day Road
 Thomas Joseph Reid Ph: 800-284-7370
 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
 Thomas Joseph Reid Ph: 800-284-7370
 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
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kansas
  Overland Park
 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
Kentucky
  Edgewood
 St. Elizabeth Medical Center
 Joseph Michael Guenther Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
  Fort Thomas
 St. Luke Hospital East
 Joseph Michael Guenther Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
  Louisville
 University of Louisville School of Medicine
 Nicolas Ajkay Ph: 866-530-5516
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
 Kristen L Fernandez Ph: 443-777-7364
 St. Agnes Hospital Cancer Center
 Richard S. Hudes Ph: 410-368-2910
  Rockville
 Cancer Trials Support Unit
 Judy C Boughey
Massachusetts
  Boston
 Dana-Farber/Brigham and Women's Cancer Center
 Katherina Z Calvillo
  Email: helen.harbett@duke.edu;marti025@surgerytrials.duke.edu
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Katherina Z Calvillo Ph: 888-823-5923
  Email: ctsucontact@westat.com
  South Weymouth
 Dana-Farber/Brigham and Women's Cancer Center at South Shore
 Katherina Z Calvillo Ph: 888-823-5923
  Email: ctsucontact@westat.com
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Tari S Stull Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Tari S Stull Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Tari S Stull Ph: 734-712-4673
  Flint
 Genesys Hurley Cancer Institute
 Tari S Stull Ph: 734-712-4673
 Hurley Medical Center
 Tari S Stull Ph: 734-712-4673
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Tari S Stull Ph: 734-712-4673
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Tari S Stull Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Tari S Stull Ph: 734-712-4673
  Pontiac
 St. Joseph Mercy Oakland
 Tari S Stull Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Tari S Stull Ph: 734-712-4673
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Nayana S Dekhne Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Tari S Stull Ph: 734-712-4673
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon Ph: 574-234-5123
  Troy
 William Beaumont Hospital - Troy Campus
 Nayana S Dekhne Ph: 248-551-7695
  Warren
 St. John Macomb Hospital
 Tari S Stull 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
  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
  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
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 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
 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
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Julie A Margenthaler Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nevada
  Henderson
 21st Century Oncology - Henderson
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Henderson
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Henderson
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada-Southeast Henderson
 John Allan Ellerton Ph: 702-384-0013
 Las Vegas Cancer Center - Henderson
 John Allan Ellerton Ph: 702-384-0013
  Las Vegas
 21st Century Oncology - Fort Apache
 John Allan Ellerton Ph: 702-384-0013
 21st Century Oncology - Vegas Sunrise
 John Allan Ellerton Ph: 702-384-0013
 21st Century Oncology - Vegas Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Fort Apache
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Shadow
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer Institute of Nevada at Summerlin Hospital Medical Center
 John Allan Ellerton Ph: 702-384-0013
 Cancer Therapy and Integrative Medicine
 John Allan Ellerton Ph: 702-384-0013
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Central Valley
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Northwest
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Southwest
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-San Martin
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Las Vegas Cancer Center-Medical Center
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Downtown Location
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Eastern Location
 John Allan Ellerton Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Allan Ellerton Ph: 702-384-0013
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Kari M Rosenkranz Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  New Brunswick
 Saint Peter's University Hospital
 Susan A McManus Ph: 732-745-8600ext6163
  Email: kcovert@saintpetersuh.com
New Mexico
  Albuquerque
 Lovelace Women's Hospital
 Calvin A Ridgeway Ph: 888-823-5923
  Email: ctsucontact@westat.com
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Kimberly J Van Zee Ph: 212-639-7202
  Poughkeepsie
 Dyson Center for Cancer Care at Vassar Brothers Medical Center
 Gregory J Zanieski Ph: 845-483-6483
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Kristin A Skinner Ph: 585-275-5830
North Carolina
  Asheboro
 Randolph Hospital
 Faera L Byerly Ph: 336-832-0821
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 David W Ollila Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  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
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Faera L Byerly 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
 Faera L Byerly Ph: 336-832-0821
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Edward A. Levine Ph: 336-713-6771
North Dakota
  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
  Cincinnati
 Christ Hospital Cancer Center
 Jennifer B Manders Ph: 513-585-2859
Oklahoma
  Oklahoma City
 Mercy Health Center
 Alan B Hollingsworth Ph: 405-752-3388
 Oklahoma University Cancer Institute
 William C Dooley Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Charlotte D Kubicky Ph: 503-494-1080
  Email: trials@ohsu.edu
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Lori C Alfonse Ph: 610-402-2273
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Lori C Alfonse Ph: 610-402-2273
  Bryn Mawr
 Bryn Mawr Hospital
 Ned Z. Carp Ph: 866-225-5654
  Email: wellenbachj@mlhs.org
  Pittsburgh
 UPMC Cancer Centers
 Gretchen M. Ahrendt Ph: 412-647-2811
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
  York
 WellSpan Health
 Thomas L. Bauer Ph: 877-441-7957
Rhode Island
  Providence
 Roger Williams Medical Center
 R. James Koness Ph: 401-456-2268
  Email: rdavies@rwmc.org
South Carolina
  Hilton Head Island
 Hilton Head Regional Medical Center
 Virginia M. Herrmann Ph: 843-792-9321
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Wade E Dosch Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Texas
  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
  Email: calgbco@calgb.org
Utah
  Cedar City
 Sandra L. Maxwell Cancer Center
 Vilija N Avizonis Ph: 801-507-3950
  Logan
 Logan Regional Hospital
 Vilija N Avizonis Ph: 801-507-3950
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 Vilija N Avizonis Ph: 801-507-3950
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Vilija N Avizonis Ph: 801-507-3950
  Provo
 Utah Valley Regional Medical Center - Provo
 Vilija N Avizonis Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 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
 LDS Hospital
 Vilija N Avizonis Ph: 801-507-3950
 Utah Cancer Specialists at UCS Cancer Center
 Vilija N Avizonis Ph: 801-507-3950
Vermont
  Berlin
 Mountainview Medical
 Michelle Sowden Ph: 802-656-8990
  Burlington
 Vermont Cancer Center at University of Vermont
 Michelle Sowden Ph: 802-656-8990
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Laurie W Cuttino Ph: 804-628-1939
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
 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
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 William L Owens Ph: 800-252-2990
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Jeanne M Johnson Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Lee G Wilke Ph: 877-405-6866
  Mequon
 Columbia Saint Mary's Hospital - Ozaukee
 Charles H. I. Tiber Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
  Milwaukee
 Aurora Sinai Medical Center
 Judy A Tjoe Ph: 800-252-2990
 Columbia-Saint Mary's Cancer Care Center
 Charles H. I. Tiber Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
 Froedtert Hospital and Medical College of Wisconsin
 Tina W Yen Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Judy A Tjoe Ph: 800-252-2990
  New Richmond
 Cancer Center of Western Wisconsin
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 William L Owens Ph: 800-252-2990
  Summit
 Aurora Medical Center
 William L Owens Ph: 800-252-2990
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Judy A Tjoe Ph: 800-252-2990
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01556243
ClinicalTrials.gov processed this data on December 10, 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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