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

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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 Boughey, Study Chair

Trial Sites

U.S.A.

California
Dublin

Epic Care-Dublin

Jon M Greif
Ph: 510-835-9900

Emeryville

Bay Area Breast Surgeons, Incorporated

James H. Feusner
Ph: 510-450-7600

Epic Care - Oakland

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

CCOP - Bay Area Tumor Institute

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

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: 989-667-6257

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

Florida
Clearwater

Morton Plant Hospital

Peter William Blumencranz
Ph: 727-461-8519

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: 989-667-6257

Coeur D'Alene

Kootenai Medical Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Post Falls

Kootenai Cancer Center - Post Falls

Benjamin Thomas Marchello
Ph: 800-648-6274

Sandpoint

Kootenai Cancer

Benjamin Thomas Marchello
Ph: 800-648-6274

Illinois
Bloomington

Illinois CancerCare - Bloomington

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

St. Joseph Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Canton

Illinois CancerCare - Canton

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Carbondale

Memorial Hospital of Carbondale

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Carthage

Illinois CancerCare - Carthage

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Centralia

Centralia Oncology Clinic

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Chicago

Resurrection Medical Center

Christopher G. Rose
Ph: 773-792-5116

University of Illinois Cancer Center

Alejandra M Perez-Tamayo
Ph: 312-567-2600

Decatur

Cancer Care Center of Decatur

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Decatur Memorial Hospital Cancer Care Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Effingham

Crossroads Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Eureka

Illinois CancerCare - Eureka

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Galesburg

Galesburg Clinic, PC

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

InterCommunity Cancer Center of Western Illinois

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Harvey

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Mark F. Kozloff
Ph: 708-915-4673
Email: clinicaltrials@ingalls.org

Kewanee

Illinois CancerCare - Kewanee Clinic

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Macomb

Illinois CancerCare - Macomb

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Ottawa

Illinois CancerCare - Ottawa

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Radiation Oncology of Northern Illinois

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Pekin

Cancer Treatment Center at Pekin Hospital

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Illinois CancerCare - Pekin

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Peoria

Illinois CancerCare - Peoria

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Methodist Medical Center of Illinois

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

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

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

OSF St. Francis Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Peru

Illinois CancerCare - Princeton

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Valley Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Princeton

Illinois CancerCare - Princeton

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Springfield

Central Illinois Hematology Oncology Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Regional Cancer Center at Memorial Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Simmons Cooper Cancer Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Springfield Clinic - Main Campus

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.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

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: 515-282-2921

Des Moines

CCOP - Iowa Oncology Research Association

Robert J Behrens
Ph: 515-282-2921

John Stoddard Cancer Center at Iowa Lutheran Hospital

Robert J Behrens
Ph: 515-282-2921

John Stoddard Cancer Center at Iowa Methodist Medical Center

Robert J Behrens
Ph: 515-282-2921

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Robert J Behrens
Ph: 515-282-2921

Medical Oncology and Hematology Associates at Mercy Cancer Center

Robert J Behrens
Ph: 515-282-2921

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: 515-282-2921

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

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Mayer Gorbaty
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

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: 989-667-6257

Battle Creek

Battle Creek Health System Cancer Care Center

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

Dearborn

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Tari S Stull
Ph: 989-667-6257

Detroit

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

Tari S Stull
Ph: 989-667-6257

Wayne State University

Mary A Kosir
Ph: 313-576-9363

Flint

Genesys Hurley Cancer Institute

Tari S Stull
Ph: 989-667-6257

Hurley Medical Center

Tari S Stull
Ph: 989-667-6257

Grand Rapids

Butterworth Hospital at Spectrum Health

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

Lacks Cancer Center at Saint Mary's Health Care

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

Jackson

Gayle M. Jacob Cancer Center at Allegiance Health

Tari S Stull
Ph: 989-667-6257

Kalamazoo

Borgess Medical Center

Sunil Nagpal
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: 989-667-6257

Livonia

St. Mary Mercy Hospital

Tari S Stull
Ph: 989-667-6257

Muskegon

Mercy General Health Partners

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

Pontiac

St. Joseph Mercy Oakland

Tari S Stull
Ph: 989-667-6257

Port Huron

Mercy Regional Cancer Center at Mercy Hospital

Tari S Stull
Ph: 989-667-6257

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: 989-667-6257

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

Traverse City

Munson Medical Center

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

Troy

William Beaumont Hospital - Troy Campus

Nayana S Dekhne
Ph: 248-551-7695

Warren

St. John Macomb Hospital

Tari S Stull
Ph: 989-667-6257

Minnesota
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

Saint Francis Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

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

Community Medical Center

Benjamin Thomas Marchello
Ph: 800-648-6274

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 Jersey
Basking Ridge

Memorial Sloan-Kettering Cancer Center - Basking Ridge

Kimberly J Van Zee
Ph: 212-639-7202

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: 505-272-6972

University of New Mexico Cancer Center

Calvin A Ridgeway
Ph: 505-272-6972

New York
Commack

Memorial Sloan-Kettering Cancer Center

Kimberly J Van Zee
Ph: 212-639-7202

Manhasset

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Dominic A Filardi
Ph: 516-562-3467

New Hyde Park

Monter Cancer Center of the North Shore-LIJ Health System

Dominic A Filardi
Ph: 516-562-3467

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

Rockville Centre

Memorial Sloan-Kettering Cancer Center - Rockville Centre

Kimberly J Van Zee
Ph: 212-639-7202

Sleepy Hollow

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Kimberly J Van Zee
Ph: 212-639-7202

North Carolina
Asheboro

Randolph Hospital

Faera L Byerly
Ph: 336-832-0821

Belmont

Gaston Hematology and Oncology Associates-Belmont

Paula A Lundgren
Ph: 704-834-2932

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

Pineville Radiation Therapy Center

Richard L. White
Ph: 704-355-2884

Presbyterian Cancer Center at Presbyterian Hospital

Justin P Favaro
Ph: 704-384-5369

University Radiation Oncology

Richard L. White
Ph: 704-355-2884

Gastonia

CaroMont Breast Surgical Specialists-Gastonia

Paula A Lundgren
Ph: 704-834-2932

CaroMont Cancer Center at Gaston Memorial Hospital

Paula A Lundgren
Ph: 704-834-2932

Gaston Hematology and Oncology Associates, PC

Paula A Lundgren
Ph: 704-834-2932

Greensboro

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Faera L Byerly
Ph: 336-832-0821

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

Ohio
Belpre

Strecker Cancer Center-Belpre

J. Philip Kuebler
Ph: 614-566-3275

Chillicothe

Adena Regional Medical Center

J. Philip Kuebler
Ph: 614-566-3275

Cincinnati

Christ Hospital Cancer Center

Jennifer B Manders
Ph: 513-585-2859

Columbus

Columbus Oncology Associates, Incorporated

J. Philip Kuebler
Ph: 614-566-3275

Doctors Hospital at Ohio Health

J. Philip Kuebler
Ph: 614-566-3275

Grant Medical Center Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Mount Carmel Health - West Hospital

J. Philip Kuebler
Ph: 614-566-3275

Riverside Methodist Hospital Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Zangmeister Center

J. Philip Kuebler
Ph: 614-566-3275

Delaware

Delaware Health Center

J. Philip Kuebler
Ph: 614-566-3275

Delaware Radiation Oncology

J. Philip Kuebler
Ph: 614-566-3275

Grady Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Lancaster

Fairfield Medical Center

J. Philip Kuebler
Ph: 614-566-3275

Marietta

Strecker Cancer Center at Marietta Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Mount Vernon

Knox Community Hospital

J. Philip Kuebler
Ph: 614-566-3275

Newark

Licking Memorial Cancer Care Program at Licking Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Newark Radiation Oncology

J. Philip Kuebler
Ph: 614-566-3275

Portsmouth

Southern Ohio Medical Center Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Springfield

Community Hospital of Springfield and Clark County

J. Philip Kuebler
Ph: 614-566-3275

Westerville

Mount Carmel St. Ann's Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Zanesville

Genesis - Good Samaritan Hospital

J. Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

Oklahoma
Oklahoma City

Mercy Health Center

Alan B Hollingsworth
Ph: 405-751-4343

Stephenson Cancer Center at the University of Oklahoma

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

Suresh G. Nair
Ph: 610-402-2273

Bethlehem

Lehigh Valley Hospital - Muhlenberg

Lori C Alfonse
Ph: 610-402-2273

Bryn Mawr

Bryn Mawr Hospital

Albert S DeNittis
Ph: 866-225-5654

Lancaster

Lancaster General Hospital

Daleela G Dodge
Ph: 717-544-0511

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

Rochelle L Ringer
Ph: 843-792-9321

South Dakota
Sioux Falls

Avera Cancer Institute

Wade E Dosch
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Texas
Amarillo

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Rakhshanda L Rahman
Ph: 806-354-5411

Dallas

Parkland Memorial Hospital

Ann Marilyn Leitch
Ph: 214-648-7097

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Ann Marilyn Leitch
Ph: 214-648-7097

Houston

Univeristy of Texas M.D. Anderson Cancer Center

Elizabeth A Mittendorf
Ph: 713-792-3245

Laredo

Doctor's Hospital of Laredo

Gary W. Unzeitig
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: 802-656-4101

Burlington

University of Vermont Cancer Center

Michelle Sowden
Ph: 802-656-4101

Virginia
Charlottesville

Martha Jefferson Hospital Cancer Care Center

Lynn T Dengel
Ph: 434-654-8400

Washington
Seattle

CCOP - Virginia Mason Research Center

Janie Grumley
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Virginia Mason Medical Center

Janie Grumley
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

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

Milwaukee

Aurora Sinai Medical Center

Judy A Tjoe
Ph: 800-252-2990

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
Cody

Big Horn Basin Cancer Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Billings Clinic-Cody

Benjamin Thomas Marchello
Ph: 800-648-6274

Sheridan

Welch Cancer Center at Sheridan Memorial Hospital

Benjamin Thomas Marchello
Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01556243
ClinicalTrials.gov processed this data on May 18, 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.