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

Basic Trial Information

Trial Description

Summary

RATIONALE: 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.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together 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.

Further Study Information

OBJECTIVES:

Primary

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

Secondary

• To compare the overall survival (OS) of patients treated with these regimens.

• To assess differences in incidence and severity of regimen-attributed adverse events in these patients.

• To provide assessment of patient risk vs benefit (positive study only).

• To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.

• To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.

Tertiary

• 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 treated with these regimens.

• To bank 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 treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to capillary-lymphovascular space involvement (positive vs negative), stromal invasion (deep vs middle vs superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs GOG). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo pelvic EBRT or 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 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy (FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at baseline and periodically during study.

Tumor tissue and blood samples may be collected and banked for future biomarker and other analysis.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed primary cervical cancer comprising one of the following cell types:

• Squamous cell carcinoma

• Adenosquamous carcinoma

• Adenocarcinoma

• Stage I-IIA disease

• Initially treated with a standard radical hysterectomy with pelvic lymphadenectomy

• Patients with depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed must meet the following criteria:

• 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

• No patients with tumor in the parametria, pelvic lymph nodes, or any other extra-uterine site or with positive surgical margins

PATIENT CHARACTERISTICS:

• GOG performance status 0-2

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphate ≤ 3 times ULN

• SGOT ≤ 3 times ULN

• No septicemia or severe infection

• No intestinal obstruction or gastrointestinal bleeding

• No post-operative fistula

• No circumstances that do not permit completion of the study or the required study follow-up

• No renal abnormalities requiring modification of radiation field (e.g., pelvic kidney or renal transplant)

• No prior malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks but ≤ 8 weeks since surgery

• No prior radiotherapy or chemotherapy for cancer of the cervix

• No prior cancer treatment that contraindicates this protocol therapy

• No concurrent brachytherapy boost

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

Sang Young Ryu

Principal Investigator

Wui-jin Koh

U.S.A.
Arizona
	Phoenix
	St. Joseph's Hospital and Medical Center
		Ivor Benjamin	Ph: 623-773-2873
California
	Burbank
	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
		Richard Friedman	Ph: 818-847-3220
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Babak Edraki	Ph: 925-674-2580
	Los Angeles
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Bobbie J Rimel	Ph: 310-423-8965
			Email: info@ccadmin.wustl.edu
	USC/Norris Comprehensive Cancer Center and Hospital
		Huyen Q Pham	Ph: 323-865-0451
		Huyen Q Pham	Ph: 323-865-0451
	Mountain View
	Palo Alto Medical Foundation
		Albert L Pisani	Ph: 650-934-7000
	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
		Eduardo R. Pajon	Ph: 888-785-6789
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo R. Pajon	Ph: 888-785-6789
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Presbyterian - St. Luke's Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Rose Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Anthony Central Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Joseph Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Littleton
	Littleton Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Parker
	Parker Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	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: 734-712-3456
	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
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		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: phri@piedmont.org
	Saint Joseph's Hospital of Atlanta
		Thomas E. Seay	Ph: 404-303-3355
	Columbus
	John B. Amos Cancer Center
		John L Currie	Ph: 860-545-5363
	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
	Cancer Research Center of Hawaii
		Michael E. Carney	Ph: 808-983-6090
	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: 734-712-3456
Illinois
	Chicago
	University of Illinois Cancer Center
		Rajul Kothari	Ph: 312-355-3046
	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
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany G. Sleckman	Ph: 913-948-5588
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
Iowa
	Ames
	McFarland Clinic, PC
		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
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Koen De Geest	Ph: 800-237-1225
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Bruce Wender	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald Bruce Wender	Ph: 712-252-0088
	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
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Julia A. Chapman	Ph: 913-588-4709
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Frederick Ueland	Ph: 859-257-3379
Louisiana
	Baton Rouge
	Woman's Hospital
		Giles Fort	Ph: 225-215-1353
			Email: clinicalreserach@marybird.com
Maine
	Portland
	Maine Medical Center - Bramhall Campus
		Ian J Bristol	Ph: 207-396-8090
			Email: wrighd@mmc.org
	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
	CCOP - Michigan Cancer Research Consortium
		Philip J. Stella	Ph: 734-712-3456
	Saint Joseph Mercy Cancer Center
		Philip J. Stella	Ph: 734-712-3456
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Detroit
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Wayne State University
		Robert T. Morris	Ph: 313-576-9363
	Flint
	Genesys Hurley Cancer Institute
		Philip J. Stella	Ph: 734-712-3456
	Hurley Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Grand Blanc
	Genesys Regional Medical Center
		Philip J. Stella	Ph: 734-712-3456
	Jackson
	Gayle M. Jacob Cancer Center at Allegiance Health
		Philip J. Stella	Ph: 734-712-3456
	Kalamazoo
	Borgess Medical Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Bronson Methodist Hospital
		Raymond Sterling Lord	Ph: 269-373-7458
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Philip J. Stella	Ph: 734-712-3456
	Livonia
	St. Mary Mercy Hospital
		Philip J. Stella	Ph: 734-712-3456
	Pontiac
	St. Joseph Mercy Oakland
		Philip J. Stella	Ph: 734-712-3456
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip J. Stella	Ph: 734-712-3456
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Philip J. Stella	Ph: 734-712-3456
	Southfield
	Providence Hospital - Southfield
		Anibal Drelichman	Ph: 248-849-5337
			Email: jaswinder.grewal@stjohn.org
	Warren
	St. John Macomb Hospital
		Philip J. Stella	Ph: 734-712-3456
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick J. Flynn	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
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Hutchinson
	Hutchinson Area Health Care
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minnesota Oncology - Maplewood
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	New Ulm
	New Ulm Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Rochester
	Mayo Clinic Cancer Center
		Harry J. Long	Ph: 507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Park Nicollet Cancer Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	United Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Stillwater
	Lakeview Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Waconia
	Ridgeview Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Woodbury
	Minnesota Oncology - Woodbury
		Patrick J. Flynn	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
	Cape Girardeau
	Saint Francis Medical Center
		Bethany G. Sleckman	Ph: 913-948-5588
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Mark I Hunter	Ph: 573-882-7440
	Rolla
	Mercy Clinic Cancer and Hematology - Rolla
		Robert L Carolla	Ph: 417-269-4520
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany G. Sleckman	Ph: 913-948-5588
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
	Springfield
	Cancer Research for the Ozarks
		Robert L Carolla	Ph: 417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert L Carolla	Ph: 417-269-4520
	St. John's Regional Health Center
		Robert L Carolla	Ph: 417-269-4520
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
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Peter C Lim	Ph: 866-513-8227
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
	Phillipsburg
	Women’s Institute for Gynecologic Cancer and Special Pelvic Surgery
		David Foster Silver	Ph: 718-765-2500
	Ridgewood
	Valley Hospital - Ridgewood
		William M. Burke	Ph: 201-634-5792
	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
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
	Las Cruces
	Memorial Medical Center
		Teresa L Rutledge	Ph: 505-272-6972
New York
	Albany
	Women's Cancer Care Associates
		Thomas P Morrissey	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
	Beth Israel Medical Center - Petrie Division
		Manjeet Chadha	Ph: 212-844-6286
	Memorial Sloan-Kettering Cancer Center
		Mario M Leitao	Ph: 212-639-7202
	St. Luke's - Roosevelt Hospital Center - St.Luke's Division
		Manjeet Chadha	Ph: 212-844-6286
	Stony Brook
	Stony Brook University Cancer Center
		Michael L. Pearl	Ph: 800-862-2215
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Linda Van Le	Ph: 877-668-0683
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Robert Victor Higgins	Ph: 704-355-2884
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins	Ph: 919-580-0000
	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
	Medcenter One Hospital Cancer Care Center
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Mid Dakota Clinic, PC
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
	St. Alexius Medical Center Cancer Center
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Esther H. Rehmus	Ph: 330-344-6348
	Summa Center for Cancer Care at Akron City Hospital
		Vivian von Gruenigen	Ph: 330-375-6101
	Chillicothe
	Adena Regional Medical Center
		J. Philip Kuebler	Ph: 614-566-3275
	Cincinnati
	University of Cincinnati
		Thomas J. Reid	Ph: 937-298-3399
			Email: uchealthnews@uc.edu
	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
	CCOP - Columbus
		J. Philip Kuebler	Ph: 502-361-8496
	Doctors Hospital at Ohio Health
		J. Philip Kuebler	Ph: 502-361-8496
	Grant Medical Center Cancer Care
		J. Philip Kuebler	Ph: 502-361-8496
	Mount Carmel Health - West Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Riverside Methodist Hospital Cancer Care
		J. Philip Kuebler	Ph: 502-361-8496
	Zangmeister Center
		J. Philip Kuebler	Ph: 502-361-8496
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Kettering
	Charles F. Kettering Memorial Hospital
		Heather S Pulaski	Ph: 937-298-3399
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	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
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler	Ph: 614-566-3275
	Portsmouth
	Southern Ohio Medical Center Cancer Center
		J. Philip Kuebler	Ph: 502-361-8496
	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: 502-361-8496
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
	Portland
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		William E Winter	Ph: 800-220-4937
			Email: cancer@lhs.org
	Northwest Cancer Specialists at Rose Quarter Cancer Center
		William E Winter	Ph: 503-413-1742
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
		Sanjiv S. Agarwala	Ph: 610-954-3582
			Email: infolink@slhn.org
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Mark A. Morgan	Ph: 215-728-4790
	Temple Cancer Center at Temple University Hospital
		Enrique Hernandez	Ph: 215-728-2983
Rhode Island
	Providence
	Women and Infants Hospital of Rhode Island
		Carolyn K McCourt	Ph: 401-274-1122
South Dakota
	Rapid City
	Black Hills Obstetrics & Gynecology LLP
		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
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		David Scott Miller	Ph: 214-648-7097
	Galveston
	University of Texas Medical Branch
		Lyuba Levine	Ph: 409-772-1950
			Email: clinical.research@utmb.edu
	Houston
	Methodist Hospital
		Aparna A Kamat	Ph: 281-277-5200
Utah
	Cedar City
	Sandra L. Maxwell Cancer Center
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Provo
	Utah Valley Regional Medical Center - Provo
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Saint George
	Dixie Regional Medical Center - East Campus
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	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
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
	Utah Cancer Specialists at UCS Cancer Center
		Ross E. Morgan	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
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
	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
	Tacoma
	Franciscan Cancer Center at St. Joseph Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Benjamin E. Greer	Ph: 206-616-8289
	Walla Walla
	St. Mary Regional Cancer Center at St. Mary Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
	Wenatchee
	Wenatchee Valley Medical Center
		Benjamin E. Greer	Ph: 206-616-8289
Wisconsin
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		David M Kushner	Ph: 877-405-6866
	Milwaukee
	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
		Scott A Kamelle	Ph: 414-649-7200
	New Richmond
	Cancer Center of Western Wisconsin
		David H. Irwin	Ph: 510-204-3428
	West Allis
	Aurora Women's Pavilion of West Allis Memorial Hospital
		Peter Johnson	Ph: 800-252-2990
Japan
	Kagoshima City, Kagoshima
	Kagoshima City Hospital
		Masayuki Hatae	Ph: 011 81 099 224 2101
	Matsuyama
	Shikoku Cancer Center
		Dina K Rooney	Ph: (888) 293-4673
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
		Kenichi Tanaka	Ph: 81-025-223-6161
Republic of Korea
	Seoul
	Asan Medical Center - University of Ulsan College of Medicine
		Young-Tak Kim	Ph: irbksh@amc.seoul.kr
	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
		Soon-Beom Kang	Ph: 011-82-760-2384
Daegu
	Jung-Ku
	Dongsan Medical Center of Keimyung University
		Chi-Heum Cho
			Email: ho@dsmc.or.kr
Incheon
	Jung-gu
	Inha University Hospital
		Eun-Seop Song	Ph: 011-82-760-2384
KOREA
	Seoul
	Catholic University of Korea College of Medicine
		Jong-Sup Park	Ph:  2258-5745-6
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
Information obtained from ClinicalTrials.gov on November 20, 2012