Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherRTOG-0924
CDR0000701128, NCI-2011-02674, NCT01368588

Trial Description

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Further Study Information

OBJECTIVES:

Primary

  • Demonstrate that prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) of patients with "unfavorable" intermediate-risk or "favorable" high-risk prostate cancer compared to NADT and high-dose prostate (P) and seminal vesicle (SV) radiation therapy (RT) using intensity-modulated RT (IMRT) or external-beam RT (EBRT) with a high-dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.

Secondary

  • Demonstrate that prophylactic WPRT improves biochemical control.
  • Determine the distant metastasis (DM)-free survival.
  • Determine the cause-specific survival (CSS).
  • Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT, P, and SV RT.
  • Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT).
  • Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (IL-1, IL-1ra, IL-6, tumor necrosis factor (TNF)-alpha, and C-reactive protein).
  • Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
  • Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.
  • Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.

OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to high-risk groups as listed in the Disease Characteristics of this abstract, type of radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and duration of androgen-deprivation therapy (short-term [6 months] vs long-term [32 months]). Patients are randomized to 1 of 2 treatment arms.

All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 6 or 32 months.

Radiotherapy begins within 8 weeks after beginning LHRH agonist/antagonist injection.

  • Arm I: Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (iodine I 125 or palladium Pd 103 may be used as the radioisotope).
  • Arm II: Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.

NOTE: * Patients undergoing brachytherapy implant receive 5 weeks of IMRT, 3D-CRT, or WPRT.

Patients may undergo blood and urine sample collection for correlative studies. Primary tumor tissue samples may also be collected.

Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and periodically during treatment. Patients who participate in the QOL portion of the study must also agree to periodic blood collection.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:
  • Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)
  • Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR
  • Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml
  • Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
  • History and/or physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration
  • Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration
  • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm
  • Patients status post a negative lymph node dissection are not eligible
  • No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute)
  • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration
  • Study entry PSA should not be obtained during the following time frames:
  • Ten-day period following prostate biopsy
  • Following initiation of hormonal therapy
  • Within 30 days after discontinuation of finasteride
  • Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis
  • E.g., carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed
  • No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy
  • No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy
  • No previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., DES), or surgical castration (orchiectomy)
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 45 days prior to the date of registration.
  • No severe, active co-morbidity, defined as any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition
  • Protocol-specific requirements may also exclude immuno-compromised patients
  • HIV testing is not required for entry into this protocol
  • No patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  • No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration (orchiectomy)
  • No prior pharmacologic androgen ablation for prostate cancer unless the onset of androgen ablation is ≤ 45 days prior to the date of registration
  • No finasteride within 30 days prior to registration
  • No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer
  • Prior chemotherapy for a different cancer is allowable
  • No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
  • NRG Oncology
Mack Roach, Principal Investigator

Trial Sites

U.S.A.

Alabama
Mobile

University of South Alabama Mitchell Cancer Institute

Roger Ove
Ph: 251-665-8000
Email: pfrancisco@usouthal.edu

Alaska
Anchorage

Providence Cancer Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Fairbanks

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Huong T. Pham
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Arizona
Peoria

Arizona Center for Cancer Care - Peoria

Terry T Lee
Ph: 623-773-2873

Phoenix

St. Joseph's Hospital and Medical Center

David G. Brachman
Ph: 877-602-4111

Scottsdale

Arizona Oncology Services Foundation

David G. Brachman
Ph: 877-602-4111

Tucson

Arizona Oncology - Tucson

Vivek S Kavadi
Ph: 281-277-5200

Arkansas
Hot Springs

St. Joseph's Mercy Cancer Center

David E. Pruitt
Ph: 501-622-2100

California
Auburn

Auburn Radiation Oncology

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Burbank

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Cameron Park

Radiation Oncology Centers - Cameron Park

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Fresno

Fresno Cancer Center

Samantha A Seaward
Ph: 626-564-3455

Greenbrae

Marin Cancer Institute at Marin General Hospital

Lloyd T Miyawaki
Ph: 415-925-7325

La Jolla

Rebecca and John Moores UCSD Cancer Center

Mack Roach
Ph: 877-827-3222
Email: mroach@radonc.ucsf.edu

Long Beach

Veterans Affairs Medical Center - Long Beach

Samar H. Azawi
Ph: 562-826-8000

Los Angeles

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Howard Mark Sandler
Ph: 310-423-8965

Modesto

Memorial Medical Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Oakland

Alta Bates Summit Medical Center - Summit Campus

James H. Feusner
Ph: 510-450-7600

Kaiser Permanente-Oakland

Samantha A Seaward
Ph: 626-564-3455

Palm Springs

Desert Regional Medical Center Comprehensive Cancer Center

Amir Lavaf
Ph: 760-416-4730

Paradise

Feather River Hospital Cancer Center

Sam Mazj
Ph: 530-876-7995
Email: haleew@ah.org

Pomona

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

Yallapragada S. Rao
Ph: 909-865-9555

Rancho Cardova

Kaiser Permanente Medical Center - Rancho Cordova

Samantha A Seaward
Ph: 626-564-3455

Rohnert Park

Rohnert Park Cancer Center

Samantha A Seaward
Ph: 626-564-3455

Roseville

Radiation Oncology Center - Roseville

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

The Permanente Medical Group-Roseville Radiation Oncology

Samantha A Seaward
Ph: 626-564-3455

Sacramento

South Sacramento Cancer Center

Samantha A Seaward
Ph: 626-564-3455

Sutter Cancer Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

University of California Davis Cancer Center

Richard K. Valicenti
Ph: 916-734-3089

San Diego

Rebecca and John Moores UCSD Cancer Center

Loren K Mell
Ph: 858-822-5354
Email: cancercto@ucsd.edu

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Mack Roach
Ph: 877-827-3222

Santa Clara

Kaiser Permanente Medical Center - Santa Clara Homestead Campus

Louis Fehrenbacher
Ph: 626-564-3455

Samantha A Seaward
Ph: 626-564-3455

South San Francisco

Kaiser Permanente Cancer Treatment Center

Samantha A Seaward
Ph: 626-564-3455

Stanford

Stanford Cancer Center

Mark K Buyyounouski
Ph: 650-498-7061
Email: ccto-office@stanford.edu

Truckee

Tahoe Forest Cancer Center

Richard K. Valicenti
Ph: 916-734-3089

Vacaville

Solano Radiation Oncology Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Colorado
Aurora

Rocky Mountain Cancer Centers - Aurora

Keren Sturtz
Ph: 888-785-6789

University of Colorado Cancer Center at UC Health Sciences Center

Brian D Kavanagh
Ph: 720-848-0650

Boulder

Rocky Mountain Cancer Centers-Boulder

Keren Sturtz
Ph: 888-785-6789

Denver

Porter Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Greeley

North Colorado Medical Center

Keren Sturtz
Ph: 888-785-6789

Longmont

Hope Cancer Care Center at Longmont United Hospital

Keren Sturtz
Ph: 888-785-6789

Loveland

McKee Medical Center

Keren Sturtz
Ph: 888-785-6789

Connecticut
Hartford

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Middletown

Middlesex Hospital Cancer Center

Susanna Hong
Ph: 860-358-2058

Delaware
Newark

Helen F. Graham Cancer Center at Christiana Hospital

Adam Raben
Ph: 302-733-6227

Adam Raben
Ph: 302-733-6227

District of Columbia
Washington

Washington Cancer Institute at Washington Hospital Center

Pamela Randolph
Ph: 202-877-8839

Florida
Jacksonville

Baptist Cancer Institute - Jacksonville

Michael R Olson
Ph: 904-202-7051

Integrated Community Oncology Network - Baptist South

Michael R Olson
Ph: 904-202-7051

Palatka

Cancer Specialists of North Florida-Putnam

Michael R Olson
Ph: 904-202-7051

Georgia
Atlanta

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Ashesh B. Jani
Ph: 404-778-1868

Piedmont Hospital

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

Saint Joseph's Hospital of Atlanta

Ashesh B. Jani
Ph: 404-778-1868

Winship Cancer Institute of Emory University

Ashesh B. Jani
Ph: 404-778-1868

Columbus

John B. Amos Cancer Center

Douglas F. Ciuba
Ph: 706-660-6404

Decatur

Veterans Affairs Medical Center - Atlanta (Decatur)

Scott Edelman
Ph: 404-321-6111ext7632

Savannah

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

John A Pablo
Ph: 800-622-6877

Hawaii
Honolulu

Hawaii Medical Center - East

Paul A. DeMare
Ph: 808-545-8548

Queen's Cancer Institute at Queen's Medical Center

Paul A. DeMare
Ph: 808-545-8548

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
Arlington Heights

Northwest Community Hospital

Stephen S. Nigh
Ph: 847-618-4968

Aurora

Rush-Copley Cancer Care Center

Ronald A Sapiente
Ph: 800-446-5532

Chicago

John H. Stroger, Jr. Hospital of Cook County

Thomas E. Lad
Ph: 312-864-6000

Louis A. Weiss Memorial Hospital

Keith L. Shulman
Ph: 773-564-5044

Decatur

Decatur Memorial Hospital Cancer Care Institute

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

Rockford

Advanced Care and Treatment Medical Group, PC

Harvey Eric Einhorn
Ph: 779-696-9400
Email: cancercare@swedishamerican.org

Springfield

Cancer Institute at St. John's Hospital

Laurent Brard
Ph: 217-545-7929

Urbana

Carle Cancer Center at Carle Foundation Hospital

Ronald A Sapiente
Ph: 800-446-5532

Indiana
Fort Wayne

Parkview Regional Cancer Center at Parkview Health

Brian K Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Radiation Oncology Associates Southwest

Brian K Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Iowa
Ames

McFarland Clinic, PC

Joseph James Merchant
Ph: 515-239-2621

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

Topeka

Cotton-O'Neil Cancer Center

David E Einspahr
Ph: 785-270-4963

Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Louisiana
Baton Rouge

Mary Bird Perkins Cancer Center - Baton Rouge

Augusto C Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

New Orleans

Ochsner Cancer Institute at Ochsner Clinic Foundation

Troy G. Scroggins
Ph: 888-562-4763

Touro Infirmary

Augusto C Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Tulane Cancer Center at Tulane University Hospital and Clinic

William R. Robinson
Ph: 504-988-6121

Maryland
Annapolis

DeCesaris Cancer Institute at Anne Arundel Medical Center

Angel E. Torano
Ph: 443-481-1320
Email: kbodenhorn@aahs.org

Baltimore

Greenebaum Cancer Center at University of Maryland Medical Center

Young Kwok
Ph: 800-888-8823

St. Agnes Hospital Cancer Center

Richard S. Hudes
Ph: 410-368-2910

Bel Air

Upper Chesapeake Medical Center

Young Kwok
Ph: 800-888-8823

Columbia

Central Maryland Oncology Center

Young Kwok
Ph: 800-888-8823

Glen Burnie

Tate Cancer Center at Baltimore Washington Medical Center

Young Kwok
Ph: 800-888-8823

Salisbury

Peninsula Regional Medical Center

Matthew L Snyder
Ph: 866-922-6237

Massachusetts
Fall River

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Jason Lee
Ph: 508-674-5600ext2515

Hyannis

Davenport-Mugar Cancer Center at Cape Cod Hospital

Daniel J Canaday
Ph: 508-862-5799

Lowell

Lowell General Hospital

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

Plymouth

Jordan Hospital Club Cancer Center

James M Koomey
Ph: 508-830-2390
Email: cancerinfo@jordanhospital.org

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Samir Narayan
Ph: 734-712-4673

Bay City

Bay Regional Medical Center

Thomas P Boike
Ph: 800-248-6777

Clinton Township

Henry Ford Macomb Hospital

Eleanor M. Walker
Ph: 313-916-1784

Dearborn

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Detroit

Josephine Ford Cancer Center at Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

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

Samir Narayan
Ph: 734-712-4673

Farmington Hills

21st Century Oncology-Farmington Hills

Jeffrey D. Forman
Ph: 248-858-6215

Flint

McLaren Cancer Institute

Hesham E. Gayar
Ph: 810-342-4071

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

Lansing

Sparrow Regional Cancer Center

Samir Narayan
Ph: 734-712-4673

Lapeer

Great Lakes Cancer Institute - Lapeer Campus

Hesham E. Gayar
Ph: 810-342-4071

Livonia

St. Mary Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Muskegon

Mercy General Health Partners

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

Owosso

Great Lakes Cancer Institute - Owosso

Hesham E. Gayar
Ph: 810-342-4071

Petoskey

Northern Michigan Hospital

Thomas P Boike
Ph: 800-248-6777

Pontiac

St. Joseph Mercy Oakland

Samir Narayan
Ph: 734-712-4673

Saginaw

Seton Cancer Institute at Saint Mary's - Saginaw

Samir Narayan
Ph: 734-712-4673

Trenton

Down River Center for Oncology

Eleanor M. Walker
Ph: 313-916-1784

Troy

21st Century Oncology-Troy

Jeffrey D. Forman
Ph: 248-858-6215

Warren

St. John Macomb Hospital

Samir Narayan
Ph: 734-712-4673

West Bloomfield

Henry Ford Medical Center - West Bloomfield

Eleanor M. Walker
Ph: 313-916-1784

Minnesota
Bemidji

MeritCare Bemidji

Preston D. Steen
Ph: 701-234-6161

Duluth

St. Luke's Hospital Cancer Care Center

Steven R Bonin
Ph: 888-823-5923
Email: ctsucontact@westat.com

Saint Louis Park

Park Nicollet Cancer Center

Paul Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Mississippi
Jackson

University of Mississippi Cancer Clinic

Srinivasan Vijayakumar
Ph: 601-815-6700

Pascagoula

Regional Cancer Center at Singing River Hospital

James E. Clarkson
Ph: 228-809-5292

Missouri
Kansas City

Kansas City Cancer Centers - North

Parvesh Kumar
Ph: 913-588-4709

Kansas City Cancer Centers - South

Parvesh Kumar
Ph: 913-588-4709

Lee's Summit

Kansas City Cancer Centers - East

Parvesh Kumar
Ph: 913-588-4709

Saint Louis

Barnes-Jewish West County Hospital

Jeff M. Michalski
Ph: 800-600-3606
Email: info@siteman.wustl.edu

David C. Pratt Cancer Center at St. John's Mercy

Jay W Carlson
Ph: 800-821-7532

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Jeff M. Michalski
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Saint Peters

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

Jeff M. Michalski
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Springfield

Hulston Cancer Center at Cox Medical Center South

Jay W Carlson
Ph: 800-821-7532

Montana
Billings

Billings Clinic Cancer Center - 801 N 29th Street

Benjamin Thomas Marchello
Ph: 800-648-6274

Great Falls

Benefis Sletten Cancer Institute

Benjamin Thomas Marchello
Ph: 800-648-6274

Nebraska
Omaha

Fred and Pamela Buffett Cancer Center

Andrew O Wahl
Ph: 800-999-5465

New Hampshire
Exeter

Center for Cancer Care at Exeter Hospital

Gary Miller Proulx
Ph: 800-439-3837

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
Egg Harbor Township

AtlantiCare Surgery Center

James C Wurzer
Ph: 609-748-7200

Mount Holly

Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County

Lemuel S. Ariaratnam
Ph: 888-847-8823

New Mexico
Las Cruces

Memorial Medical Center

Cherie J. Hayostek
Ph: 575-521-1554

New York
Bay Shore

Southside Hospital

Louis Potters
Ph: 516-562-3467

Brooklyn

New York Methodist Hospital

Sameer Rafla-Demetrious
Ph: 718-780-5240

Cooperstown

Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

Naoyuki G Saito
Ph: 607-547-3073
Email: diana.crean@bassett.org

Elmira

Falck Cancer Center at Arnot Ogden Medical Center

Chi K Tsang
Ph: 607-271-7000

New Hyde Park

Monter Cancer Center of the North Shore-LIJ Health System

Louis Potters
Ph: 516-562-3467

North Carolina
Durham

Duke Cancer Institute

W. Robert Lee
Ph: 888-275-3853

Morehead City

Coleman Radiation Oncology Center at Carter General Hospital

Michael A Papagikos
Ph: 910-251-1839

Raleigh

Rex Cancer Center at Rex Hospital

Nathan C Sheets
Ph: 919-784-7209

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

Winston-Salem

Forsyth Regional Cancer Center at Forsyth Medical Center

Beverly D Moose
Ph: 336-277-8887

Wake Forest University Comprehensive Cancer Center

Bart Frizzell
Ph: 336-713-6771

North Dakota
Fargo

Roger Maris Cancer Center at MeritCare Hospital

Preston D. Steen
Ph: 701-234-6161

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Mitchell Lee Fromm
Ph: 330-344-6348

Summa Center for Cancer Care at Akron City Hospital

Charles A Kunos
Ph: 330-375-6101

Barberton

Barberton Citizens Hospital

Charles A Kunos
Ph: 330-375-6101

Beachwood

UHHS Chagrin Highlands Medical Center

Rodney J Ellis
Ph: 800-641-2422

Chardon

Geauga Regional Hospital

Rodney J Ellis
Ph: 800-641-2422

Chillicothe

Adena Regional Medical Center

J. Philip Kuebler
Ph: 614-566-3275

Cleveland

Case Comprehensive Cancer Center

Rodney J Ellis
Ph: 800-641-2422

Columbus

Zangmeister Center

J. Philip Kuebler
Ph: 614-566-3275

Elyria

Mercy Cancer Center - Elyria

Rodney J Ellis
Ph: 800-641-2422

Maumee

Northwest Ohio Oncology Center

Rex B Mowat
Ph: 800-444-3561

Medina

Summa Health Center at Lake Medina

Charles A Kunos
Ph: 330-375-6101

Mentor

Lake/University Ireland Cancer Center

Rodney J Ellis
Ph: 800-641-2422

Middleburg Heights

Southwest General Health Center

Rodney J Ellis
Ph: 800-641-2422

Portsmouth

Southern Ohio Medical Center Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Ravenna

Robinson Radiation Oncology

Mitchell Lee Fromm
Ph: 330-344-6348

Sandusky

University Hospitals Ireland Cancer Center at Firelands Regional Medical Center

Rodney J Ellis
Ph: 800-641-2422

Toledo

St. Anne Mercy Hospital

Rex B Mowat
Ph: 800-444-3561

Westlake

UHHS Westlake Medical Center

Rodney J Ellis
Ph: 800-641-2422

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Oregon
Clackamas

Clackamas Radiation Oncology Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Grants Pass

Three Rivers Community Hospital

Gordon L. Metz
Ph: 541-789-6176

Medford

Dubs Cancer Center at Rogue Valley Medical Center

Gordon L. Metz
Ph: 541-789-6176

Providence Cancer Center at PMCC

Gordon L. Metz
Ph: 541-789-6176

Portland

Providence Cancer Center at Providence Portland Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Providence St. Vincent Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Pennsylvania
Abington

Rosenfeld Cancer Center at Abington Memorial Hospital

Wayne H Pinover
Ph: 215-481-2402

Furlong

Fox Chase Cancer Center Buckingham

Eric Horwitz
Ph: 215-728-4790

Gettysburg

Adams Cancer Center

Amit B. Shah
Ph: 877-441-7957

Hanover

Cherry Tree Cancer Center

Amit B. Shah
Ph: 877-441-7957

Philadelphia

Fox Chase Cancer Center - Philadelphia

Eric Horwitz
Ph: 215-728-4790

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Michael L Haas
Ph: 610-988-9323

York

WellSpan Health

Amit B. Shah
Ph: 877-441-7957

South Carolina
Charleston

Hollings Cancer Center at Medical University of South Carolina

David T Marshall
Ph: 843-792-9321

Greenville

Cancer Centers of the Carolinas - Faris Road

David L Grisell
Ph: 864-241-6251

CCOP - Greenville

David L Grisell
Ph: 864-241-6251

Greenwood

Self Regional Cancer Center at Self Regional Medical Center

David T Marshall
Ph: 843-792-9321

Greer

Gibbs Cancer Center-Pelham

Patricia C Griffin
Ph: 800-486-5941

Hilton Head Island

Hilton Head Radiation Oncology Center

John A Pablo
Ph: 800-622-6877

Seneca

Cancer Centers of the Carolinas - Seneca

David L Grisell
Ph: 864-241-6251

Spartanburg

Cancer Centers of the Carolinas - Spartanburg

David L Grisell
Ph: 864-241-6251

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Patricia C Griffin
Ph: 800-486-5941

Tennessee
Kingsport

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Asheesh Shipstone
Ph: 423-578-8538

Texas
Dallas

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

Raquibul Hannan
Ph: 214-648-7097

Fort Sam Houston

Brooke Army Medical Center

Bronwyn R Stall
Ph: 210-916-4837

Galveston

University of Texas Medical Branch

Martin Colman
Ph: 409-772-1950
Email: clinical.research@utmb.edu

Houston

Ben Taub General Hospital

Mark D Bonnen
Ph: 713-798-1354
Email: burton@bcm.edu

League City

UTMB Cancer Center at Victory Lakes

Martin Colman
Ph: 409-772-1950
Email: clinical.research@utmb.edu

San Antonio

University of Texas Health Science Center at San Antonio

Tony Y. Eng
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Utah
American Fork

American Fork Hospital

R. Jeffrey Lee
Ph: 801-507-3950

Murray

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

Provo

Utah Valley Regional Medical Center - Provo

R. Jeffrey Lee
Ph: 801-507-3950

Saint George

Dixie Regional Medical Center - East Campus

R. Jeffrey Lee
Ph: 801-507-3950

Salt Lake City

Huntsman Cancer Institute at University of Utah

Jonathan D Tward
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Utah Cancer Specialists at UCS Cancer Center

R. Jeffrey Lee
Ph: 801-507-3950

Vermont
Bennington

Southwestern Vermont Regional Cancer Center

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

Berlin

Mountainview Medical

Harold James Wallace
Ph: 802-656-4101

Burlington

University of Vermont Medical Center

Harold James Wallace
Ph: 802-656-4101

Saint Johnsbury

Norris Cotton Cancer Center - North

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

Virginia
Charlottesville

University of Virginia Cancer Center

Timothy N Showalter
Ph: 434-243-6143

Fishersville

Augusta Medical Center Cancer Center

Robert M Kyler
Ph: 540-689-7000

Hampton

Sentara Cancer Institute at Sentara CarePlex Hospital

Mark E Shaves
Ph: 757-388-2406

Harrisonburg

RMH Regional Cancer Center at Rockingham Memorial Hospital

Heather Anne W Morgan
Ph: 540-689-7000

Norfolk

Sentara Cancer Institute at Sentara Norfolk General Hospital

Mark E Shaves
Ph: 757-388-2406

Portsmouth

Naval Medical Center - Portsmouth

Edward F Miles
Ph: 757-953-5939

Virginia Beach

Coastal Cancer Center at Sentara Virginia Beach General Hospital

Mark E Shaves
Ph: 757-388-2406

Washington
Federal Way

St. Francis Hospital

Huong T. Pham
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Seattle

CCOP - Virginia Mason Research Center

Huong T. Pham
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Virginia Mason Medical Center

Huong T. Pham
Ph: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Vancouver

Southwest Washington Medical Center Cancer Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

West Virginia
Morgantown

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Malcolm D Mattes
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Wisconsin
Appleton

Fox Valley Surgical Associates at Appleton Medical Center

Michael E Ray
Ph: 920-380-1500

Eau Claire

Luther Midlelfort Hospital

Sakti Chakrabarti
Ph: 715-838-6356

Green Bay

St. Mary's Hospital Medical Center - Green Bay

James L Leenstra
Ph: 920-433-8889

St. Vincent Hospital Regional Cancer Center

James L Leenstra
Ph: 920-433-8889

Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

Mitchell H. Pincus
Ph: 800-252-2990

Johnson Creek

UW Cancer Center Johnson Creek

Gregory M. Cooley
Ph: 920-699-3500
Email: lynda.persico@uwmf.wisc.edu

La Crosse

Franciscan Skemp Healthcare - La Crosse Campus

David J Schwartz
Ph: 608-392-9462

Gundersen Lutheran Center for Cancer and Blood

Collin D Driscoll
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Marinette

Bay Area Cancer Care Center at Bay Area Medical Center

James L Leenstra
Ph: 920-433-8889

Mequon

Columbia Saint Mary's Hospital - Ozaukee

Craig A Schulz
Ph: 414-326-2675
Email: clinicaltrials@columbia-stmarys.org

Milwaukee

Columbia-Saint Mary's Cancer Care Center

Craig A Schulz
Ph: 414-326-2675
Email: clinicaltrials@columbia-stmarys.org

Froedtert Hospital and Medical College of Wisconsin

Colleen A. Lawton
Ph: 414-805-4380

Veterans Affairs Medical Center - Milwaukee

Elizabeth M. Gore
Ph: 414-805-4380

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

Mitchell H. Pincus
Ph: 800-252-2990

Racine

All Saints Cancer Center at Wheaton Franciscan Healthcare

James H. Taylor
Ph: 414-874-4541
Email: Kelli.holton@wfhc.org

Sheboygan

Vince Lombardi Cancer Clinic - Sheboygan

Mitchell H. Pincus
Ph: 800-252-2990

Sturgeon Bay

Door County Cancer Center at Door County Memorial Hospital

James L Leenstra
Ph: 920-433-8889

Summit

Aurora Medical Center

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

Wisconsin Rapids

Riverview UW Cancer Center at Riverview Hospital

Gregory M. Cooley
Ph: 920-699-3500
Email: lynda.persico@uwmf.wisc.edu

Canada

Alberta
Edmonton

Cross Cancer Institute at University of Alberta

Brita L Danielson
Ph: 780-432-8500

Ontario
Toronto

Odette Cancer Centre at Sunnybrook

Hans T Chung
Ph: 416-480-5000

Quebec
Montreal

Hopital Notre-Dame du CHUM

Jean-Paul Bahary
Ph: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

McGill Cancer Centre at McGill University

Fabio L Cury
Ph: 514-398-1444
Email: penny.chipman@mcgill.ca

Quebec City

Centre Hospitalier Universitaire de Quebec

Eric Vigneault
Ph: 418-525-4444

Saskatchewan
Regina

Allan Blair Cancer Centre at Pasqua Hospital

Evgeny Sadikov
Ph: 306-766-2213

Saskatoon

Saskatoon Cancer Centre at the University of Saskatchewan

Ali A El-Gayed
Ph: 306-655-2914

Israel

Petach Tikva

Rabin Medical Center - Beilinson Campus

Aaron M Allen
Ph: 888-823-5923
Email: ctsucontact@westat.com

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01368588
ClinicalTrials.gov processed this data on February 27, 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.