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Clinical Trials (PDQ®)

Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITissue collection/Repository, TreatmentActive18 and overNCI, OtherGOG-0263
NCI-2011-02037, CDR0000670125, U10CA180868, U10CA027469, NCT01101451

Trial Description

Summary

This randomized phase III trial studies radiation therapy with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy.

SECONDARY OBJECTIVES:

I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.

II. To assess differences (across treatment arms) in incidence and severity of therapy-attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE).

III. To provide assessment of patient risk vs benefit (positive study only). IV. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events).

TERTIARY OBJECTIVES:

I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone.

II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.

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

ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.

ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
  • Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
  • Positive capillary-lymphovascular space involvement and one of the following:
  • Deep third penetration
  • Middle third penetration, clinical tumor ≥ 2 cm
  • Superficial third penetration, clinical tumor ≥ 5 cm
  • Negative capillary-lymphatic space involvement
  • Middle or deep third penetration, clinical tumor ≥ 4 cm
  • Absolute neutrophil count (ANC) ≥ 1,500/mcl
  • Platelets ≥ 100,000/mcl
  • Creatinine ≤ upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min
  • Bilirubin ≤ 1.5 times normal
  • Alkaline phosphate ≤ 3 times normal
  • Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times normal
  • Gynecologic Oncology Group (GOG) performance status 0, 1, 2
  • Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
  • Patients who have met the pre-entry requirements
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

  • Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
  • Patients with septicemia or severe infection
  • Patients with intestinal obstruction or gastrointestinal bleeding
  • Patients with postoperative fistula
  • Patients with cervix cancer who have received any previous radiation or chemotherapy
  • Patients whose circumstances do not permit completion of the study or the required follow-up
  • Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
  • Patients with GOG performance status of 3 or 4
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Sang RyuPrincipal Investigator

Trial Sites

U.S.A.
Alaska
  Anchorage
 Alaska Breast Care and Surgery LLC
 Alison K Conlin Ph: 503-215-6412
 Alaska Women's Cancer Care
 Alison K Conlin Ph: 503-215-6412
 Anchorage Oncology Centre
 Alison K Conlin Ph: 503-215-6412
 Katmai Oncology Group
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
Arizona
  Phoenix
 St. Joseph's Hospital and Medical Center
 John H Farley Ph: 877-602-4111
California
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Alison K Conlin Ph: 503-215-6412
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Babak Edraki Ph: 925-674-2580
  Modesto
 Memorial Medical Center
 Jorge A Garcia-Young Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Mountain View
 Palo Alto Medical Foundation
 Albert L Pisani Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Pomona
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Alberto A Mendivil Ph: 949-642-5165
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Babak Edraki Ph: 925-674-2580
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Eduardo R. Pajon Ph: 888-336-8262
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
District of Columbia
  Washington
 Sibley Memorial Hospital
 Mildred Rodriguez Chernofsky Ph: 202-243-2373
Florida
  Altamonte Springs
 Florida Hospital - Altamonte
 James E Kendrick Ph: 407-303-5623
  Deerfield Beach
 University of Miami/Deerfield Beach
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Kissimmee
 Florida Hospital Kissimmee
 James E Kendrick Ph: 407-303-5623
  Miami
 Jackson Memorial Hospital
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 James E Kendrick Ph: 407-303-5623
 Florida Hospital East Orlando
 James E Kendrick Ph: 407-303-5623
 Florida Urology Associates-Orlando
 James E Kendrick Ph: 407-303-5623
  Winter Park
 Florida Hospital Cancer Institute at Winter Park
 James E Kendrick Ph: 407-303-5623
Georgia
  Atlanta
 Northside Hospital Cancer Center
 Guilherme C. Cantuaria Ph: 404-303-3355
  Email: clinicaltrials@northside.com
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
 Saint Joseph's Hospital of Atlanta
 Thomas E. Seay Ph: 404-303-3355
 Winship Cancer Institute of Emory University
 Namita Khanna Ph: 404-778-1868
  Columbus
 John B. Amos Cancer Center
 Gregory P Sfakianos Ph: 706-660-6404
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Thomas E. Seay Ph: 404-303-3355
  Gainesville
 Northeast Georgia Medical Center
 Andrew E Green Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Marietta
 Kennestone Cancer Center at Wellstar Kennestone Hospital
 Thomas E. Seay Ph: 404-303-3355
  Riverdale
 Southern Regional Medical Center
 Thomas E. Seay Ph: 404-303-3355
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 James J Burke Ph: 912-350-8568
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 William Edward Richards Ph: 800-622-6877
  Email: uchealthnews@uc.edu
Hawaii
  Honolulu
 MBCCOP - Hawaii
 Michael E. Carney Ph: 808-983-6090
 Queen's Cancer Institute at Queen's Medical Center
 Michael E. Carney Ph: 808-983-6090
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
Illinois
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Ronald Keith Potkul Ph: 708-226-4357
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
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
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Jeanne M Schilder Ph: 317-274-2552
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 937-775-1350
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
 Mercy Cancer Center - West Lakes
 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
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 David P Bender Ph: 800-237-1225
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
  Spencer
 Abben Cancer Center at Spencer Hospital
 Luis A Rojas-Espaillat Ph: 800-657-4377
  Email: Jan.Healy@avera.org
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kentucky
  Crestview Hills
 Oncology Hematology Care, Incorporated - Crestview Hills
 Howard M. Gross Ph: 937-775-1350
  Lexington
 University of Kentucky Chandler Medical Center
 Frederick Ueland Ph: 859-257-3379
Louisiana
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
 Woman's Hospital
 Giles Fort Ph: 225-215-1353
  Email: clinicalreserach@marybird.com
  New Orleans
 Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
  Email: wrighd@mmc.org
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Paul Celano Ph: 443-849-3706
  Bethesda
 National Naval Medical Center
 Michael P Stany Ph: 301-319-2100
  Silver Spring
 Holy Cross Hospital
 Sheela D Modin Ph: 310-754-7552
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
 Wayne State University
 Robert T. Morris Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-4673
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-4673
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
  Southfield
 Providence Hospital - Southfield
 Vinay Kumar Malviya Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Health Partners Inc
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Hennepin County Medical Center - Minneapolis
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Harry J. Long Ph: 507-538-7623
  Saint Louis Park
 Park Nicollet Cancer Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James E. Clarkson Ph: 228-809-5292
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Bonne Terre
 Parkland Health Center-Bonne Terre
 Alan Philip Lyss Ph: 800-392-0936
  Branson
 Skaggs Cancer Center at Skaggs Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Mark I Hunter Ph: 573-882-7440
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Joplin
 Freeman Cancer Institute at Freeman Health System
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Mercy Clinic St. Louis Cancer and Breast Institute
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Sainte Genevieve
 Sainte Genevieve County Memorial Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Sullivan
 Missouri Baptist Sullivan Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Sunset Hills
 Missouri Baptist Outpatient Center-Sunset Hills
 Alan Philip Lyss Ph: 800-392-0936
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Peter C. Morris Ph: 402-354-7939
  Email: kathryn.bartz@nmhs.org
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Leslie R. DeMars Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Long Branch
 Monmouth Medical Center
 Mitchell F Weiss Ph: 732-923-7689
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Randolph B Deger Ph: 888-847-8823
  Paramus
 The Valley Hospital-Luckow Pavilion
 William M. Burke Ph: 212-305-8615
  Toms River
 J. Phillip Citta Regional Cancer Center at Community Medical Center
 David J D'Ambrosio Ph: 732-818-3882
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Ramakrishna Sudhindra Ph: 856-641-7933
  Voorhees
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Randolph B Deger Ph: 888-847-8823
  Westwood
 Oncology Hematology and Internal Medicine
 William M. Burke Ph: 212-305-8615
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates, Incorporated
 Carolyn Y. Muller Ph: 505-272-6972
 University of New Mexico Cancer Center
 Carolyn Y. Muller Ph: 505-272-6972
 Samuel Ryu
  Email: sryu1@hfhs.org
  Las Cruces
 Memorial Medical Center
 Carolyn Y. Muller Ph: 505-272-6972
New York
  Albany
 Women's Cancer Care Associates
 Daniel Casey Kredentser Ph: 518-458-1390
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Mark H. Einstein Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Brooklyn
 SUNY Downstate Medical Center
 Ovadia Abulafia Ph: 718-270-8216
  Email: sima.terebelo@downstate.edu
  New York
 Memorial Sloan-Kettering Cancer Center
 Mario M Leitao Ph: 212-639-7202
  Stony Brook
 Stony Brook University Cancer Center
 Michael L. Pearl Ph: 800-862-2215
North Carolina
  Asheboro
 Randolph Hospital
 James M Granfortuna Ph: 336-832-0821
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 James M Granfortuna Ph: 336-832-0821
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 James M Granfortuna Ph: 336-832-0821
  Mebane
 Cone Heath Cancer Center at Mebane
 James M Granfortuna Ph: 336-832-0821
  Reidsville
 Annie Penn Cancer Center
 James M Granfortuna Ph: 336-832-0821
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Samuel S. Lentz Ph: 336-713-6771
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward J. Wos Ph: 701-323-5760
  Email: tfischer@mohs.org
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Vivian von Gruenigen Ph: 330-375-6101
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 800-446-5532
  Cincinnati
 Oncology Hematology Care Inc - Western Hills
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Anderson
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Blue Ash
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Kenwood
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road
 Howard M. Gross Ph: 937-775-1350
  Cleveland
 Case Comprehensive Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Peter Graham Rose Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 Peter Graham Rose Ph: 866-223-8100
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 800-446-5532
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 800-446-5532
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 800-446-5532
 Zangmeister Center
 J. Philip Kuebler Ph: 502-361-8496
  Dayton
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 937-775-1350
 Good Samaritan Hospital
 Howard M. Gross Ph: 937-775-1350
 Grandview Hospital
 Thomas J. Reid Ph: 937-298-3399
  Email: uchealthnews@uc.edu
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 937-775-1350
  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: 800-446-5532
  Fairfield
 Oncology Hematology Care, Incorporated - Fairfield Healthplex
 Howard M. Gross Ph: 937-775-1350
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 937-775-1350
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 937-775-1350
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 937-775-1350
  Kettering
 Charles F. Kettering Memorial Hospital
 Thomas J. Reid Ph: 937-298-3399
  Email: uchealthnews@uc.edu
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Peter Graham Rose Ph: 866-223-8100
  Mentor
 Lake/University Ireland Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
  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: 800-446-5532
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 800-446-5532
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 937-775-1350
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 800-446-5532
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 William E Winter Ph: 503-280-1223
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Nicholas P Taylor Ph: 610-954-3582
  Email: infolink@slhn.org
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Radhika P Gogoi Ph: 570-271-5251
  Email: wellenbachj@mlhs.org
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Penny R Anderson Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Allison Zibelli Ph: 215-955-6084
 Temple Cancer Center at Temple University Hospital
 Enrique Hernandez Ph: 215-728-2983
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Radhika P Gogoi Ph: 570-271-5251
  Email: wellenbachj@mlhs.org
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Carolyn K McCourt Ph: 800-600-3606
  Email: info@siteman.wustl.edu
South Dakota
  Rapid City
 Black Hills Obstetrics & Gynecology LLP
 Helen L. Frederickson Ph: 605-343-9224
 Rapid City Regional Hospital
 Helen L. Frederickson Ph: 605-343-9224
  Sioux Falls
 Avera Cancer Institute
 Luis A Rojas-Espaillat Ph: 800-657-4377
  Email: Jan.Healy@avera.org
Tennessee
  Knoxville
 U.T. Medical Center Cancer Institute
 Larry C Kilgore Ph: 865-544-9773
Texas
  Austin
 University Medical Center Brackenridge
 Mark A Crozier Ph: 512-324-7991
  Dallas
 Parkland Memorial Hospital
 David Scott Miller Ph: 214-648-7097
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Houston
 Methodist Hospital
 Aparna A Kamat Ph: 713-790-2700
Utah
  American Fork
 American Fork Hospital
 Jeffrey E Lee Ph: 713-792-3245
  Cedar City
 Sandra L. Maxwell Cancer Center
 Jeffrey E Lee Ph: 713-792-3245
  Logan
 Logan Regional Hospital
 Jeffrey E Lee Ph: 713-792-3245
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 Jeffrey E Lee Ph: 713-792-3245
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Jeffrey E Lee Ph: 713-792-3245
  Provo
 Utah Valley Regional Medical Center - Provo
 Jeffrey E Lee Ph: 713-792-3245
  Saint George
 Dixie Regional Medical Center - East Campus
 Jeffrey E Lee Ph: 713-792-3245
  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
 Jeffrey E Lee Ph: 713-792-3245
 Utah Cancer Specialists at UCS Cancer Center
 Jeffrey E Lee Ph: 713-792-3245
Virginia
  Portsmouth
 Naval Medical Center - Portsmouth
 Edward F Miles Ph: 757-953-5939
Washington
  Bellingham
 PeaceHealth Medical Group, PC at St. Joseph Hospital
 Benjamin E. Greer Ph: 206-616-8289
  Bremerton
 Harrison Medical Center
 Benjamin E. Greer Ph: 206-616-8289
 Olympic Hematology and Oncology
 Benjamin E. Greer Ph: 206-616-8289
  Everett
 Providence Regional Cancer Partnership
 Benjamin E. Greer Ph: 206-616-8289
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 Benjamin E. Greer Ph: 206-616-8289
  Poulsbo
 Harrison Poulsbo Hematology and Onocology
 Benjamin E. Greer Ph: 206-616-8289
  Seattle
 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
 Benjamin E. Greer Ph: 206-616-8289
 Group Health Central Hospital
 Benjamin E. Greer Ph: 206-616-8289
 Pacific Gynecology Specialists
 Benjamin E. Greer Ph: 206-616-8289
 Seattle Cancer Care Alliance
 Benjamin E. Greer Ph: 206-616-8289
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Benjamin E. Greer Ph: 206-616-8289
 Swedish Cancer Institute at Northwest Hospital & Medical Center
 Benjamin E. Greer Ph: 206-616-8289
 University Cancer Center at University of Washington Medical Center
 Benjamin E. Greer Ph: 206-616-8289
  Sequim
 Olympic Medical Cancer Center
 Benjamin E. Greer Ph: 206-616-8289
  Spokane
 Cancer Care Northwest - Spokane South
 Benjamin E. Greer Ph: 206-616-8289
 Rockwood Clinic Cancer Treatment Center
 Benjamin E. Greer Ph: 206-616-8289
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
  Walla Walla
 St. Mary Regional Cancer Center at St. Mary Medical Center
 Benjamin E. Greer Ph: 206-616-8289
  Wenatchee
 Confluence Health - Wenatchee Valley Medical Center
 Benjamin E. Greer Ph: 206-616-8289
Wisconsin
  Grafton
 Aurora Cancer Care-Grafton
 Peter Johnson Ph: 414-649-5717
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Milwaukee
 Aurora Sinai Medical Center
 Peter Johnson Ph: 414-649-5717
 Froedtert Hospital and Medical College of Wisconsin
 William H Bradley Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  New Richmond
 Cancer Center of Western Wisconsin
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Summit
 Aurora Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Peter Johnson Ph: 414-649-5717
Japan
  Kagoshima City, Kagoshima
 Kagoshima City Hospital
 Toshiaki Nakamura Ph: 011 81 099 224 2101
  Matsuyama
 Shikoku Cancer Center
 Takayoshi Nogawa Ph: 089-999-1172
  Osaka, Osaka
 Kinki University School of Medicine
 Masaki Mandai Ph: 072-366-0221
Aoba-ku
  Sendai
 Tohoku University Graduate School of Medicine
 Nobuo Yaegashi
  Email: med-som@bureau.tohoku.ac.jp
Hiroshima
  Kure
 National Hospital Organization - Medical Center of Kure
 Hiroko Nakamura Ph: (0823) 22-3111
Iwate
  Morioka
 Iwate Medical University Hospital
 Toru Sugiyama Ph: 019-651-5111
Niigata
  Niigata City
 Niigata University Medical and Dental Hospital
 Takayuki Enomoto Ph: 81-025-223-6161
Republic of Korea
  Seoul
 Gangnam Severance Hospital
 Jae-Hoon Kim
  Email: clinical.trial@bms.com
 Korea Cancer Center Hospital
 Beob-Jong Kim Ph: 011-82-02-9702-114
 Seoul National University Hospital
 Jae W Kim Ph: 011-82-760-2384
Daegu
  Jung-Ku
 Dongsan Medical Center of Keimyung University
 Chi-Heum Cho
  Email: ho@dsmc.or.kr
Gyeonggi-do
  Goyang-si
 National Cancer Center - Korea
 Sang Y Park Ph: 011-82-760-2384
Incheon
  Jung-gu
 Inha University Hospital
 Eun-Seop Song Ph: 011-82-760-2384
Kyeonggi-do
  Seongnam City
 Seoul National University Bundang Hospital
 Kidong Kim Ph: 011-82-02-9702-114

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01101451
ClinicalTrials.gov processed this data on October 20, 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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