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

This study is currently recruiting participants.
Verified February 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01101451
First received: April 9, 2010
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
 Drug: cisplatin
Radiation: external beam radiation therapy
Radiation: intensity-modulated radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Local control [ Designated as safety issue: No ]
  • Frequence and severity of adverse events as assessed by NCI CTCAE active version [ Designated as safety issue: Yes ]
  • Treatment compliance [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Smoking history: prevalence of active smoking and extent of nicotine dependence [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: April 2010
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5½ weeks.
 Radiation: external beam radiation therapy
Undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Undergo radiotherapy
Experimental: 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.
 Drug: cisplatin
Given IV
Radiation: external beam radiation therapy
Undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Undergo radiotherapy

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101451

  Hide Study Locations
Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Ivor Benjamin     602-406-3000        
United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente     818-847-3220        
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ilana Cass     310-423-3277        
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus Recruiting
New Britain, Connecticut, United States, 06050
Contact: Clinical Trials Office - George Bray Cancer Center     860-224-5660        
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Mildred R. Chernofsky     202-537-4000        
United States, Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute     407-303-5623        
United States, Georgia
Northside Hospital Cancer Center Recruiting
Atlanta, Georgia, United States, 30342-1611
Contact: Clinical Trials Office - Northside Hospital Cancer Center     404-303-3355        
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer     912-350-8568        
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii     808-586-2979        
MBCCOP - Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Michael E. Carney, MD     808-983-6090        
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center Recruiting
Alton, Illinois, United States, 62002
Contact: Bethany G. Sleckman, MD     314-251-7057        
Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma, MD     630-856-6757        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Bethany G. Sleckman, MD     314-251-7057        
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center     317-274-2552        
St. Vincent Oncology Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton, MD     317-415-6740        
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC     515-239-2621        
Medical Oncology and Hematology Associates - West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens     515-875-9713        
John Stoddard Cancer Center at Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa M     515-241-6727        
CCOP - Iowa Oncology Research Association Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens     515-244-7586        
John Stoddard Cancer Center at Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa L     515-241-8704        
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens     515-282-2921        
Medical Oncology and Hematology Associates at Mercy Cancer Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens     515-643-8740        
Mercy Cancer Center at Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens     515-643-8206        
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD     712-252-0088        
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit     913-588-4709        
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of     859-257-3379        
United States, Louisiana
Woman's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70815
Contact: Giles Fort, MD     225-358-1071        
United States, Maryland
Greater Baltimore Medical Center Cancer Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Clinical Trials Office - Greater Baltimore Medical Center Canc     443-849-3706        
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Clinical Trials Office - Holy Cross Hospital     310-754-7552        
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn, MD     612-863-8585        
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn, MD     612-863-8585        
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital     612-625-3650        
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn, MD     612-863-8585        
Minnesota Oncology Hematology, PA - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD     612-863-8585        
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD     612-863-8585        
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn     612-873-5911        
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute     612-863-5654        
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor     763-520-1893        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-863-8585        
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-863-8585        
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD     612-863-8585        
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn, MD     612-863-8585        
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center     651-254-1517        
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Patrick J. Flynn, MD     612-863-8585        
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn, MD     612-863-8585        
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Patrick J. Flynn, MD     612-863-8585        
Minnesota Oncology Hematology, PA - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn, MD     612-863-8585        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen, MD     601-984-5590        
Regional Cancer Center at Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson, MD     228-374-6296        
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Bethany G. Sleckman, MD     314-251-7057        
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center     573-882-7440        
CCOP - St. Louis-Cape Girardeau Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD     314-251-7057        
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J     314-251-6770        
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla     417-269-5257        
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla     417-269-4520        
St. John's Regional Health Center Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert L. Carolla     417-820-2000        
United States, Nebraska
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris, MD     402-354-5250        
United States, Nevada
Women's Cancer Center - La Canada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nick M. Spirtos, MD     408-866-3843        
Renown Institute for Cancer at Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Peter C. Lim     775-982-5050        
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Recruiting
Marlton, New Jersey, United States, 08053
Contact: Clinical Trials Office - Fox Chase Virtua Health Cancer Progra     888-847-8823        
Women's Institute for Gynecologic Cancer and Special Pelvic Surgery Recruiting
Phillipsburg, New Jersey, United States, 08865
Contact: David F. Silver, MD     702-427-4999        
Valley Hospital - Ridgewood Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: William M. Burke, MD     734-936-6886        
United States, New Mexico
Southwest Gynecologic Oncology Associates, Incorporated Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Carolyn Y. Muller, MD     505-272-0185        
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
University of New Mexico Cancer Center - South Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Carolyn Y. Muller, MD     505-272-0185        
United States, New York
Women's Cancer Care Associates Recruiting
Albany, New York, United States, 12208
Contact: Thomas P. Morrissey     518-458-1390        
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Ovadia Abulafia, MD     718-270-2152        
Beth Israel Medical Center - Petrie Division Recruiting
New York, New York, United States, 10003-3803
Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D     212-844-6286        
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario M. Leitao, Jr.     212-639-8895        
St. Luke's - Roosevelt Hospital Center - St.Luke's Division Recruiting
New York, New York, United States, 10025
Contact: Manjeet Chadha     212-523-4000        
Stony Brook University Cancer Center Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center     800-862-2215        
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente     877-668-0683; 919-966-4432        
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, North Dakota
Bismarck Cancer Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Edward J. Wos, DO     701-323-5741        
Medcenter One Hospital Cancer Care Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Edward J. Wos, DO     701-323-5741        
Mid Dakota Clinic, PC Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Clinical Trials Office - Mid Dakota Clinic, PC     701-530-6950        
St. Alexius Medical Center Cancer Center Recruiting
Bismarck, North Dakota, United States, 58502
Contact: Clinical Trials Office - St. Alexius Medical Center Cancer Cen     701-530-6950        
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Eric L. Jenison, MD     330-344-6041        
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital     330-375-6101        
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Clinical Trials Office - Adena Regional Medical Center     877-779-7585        
Charles M. Barrett Cancer Center at University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: William E. Richards     806-796-1317        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Cleveland Clinic Cancer Center at Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai     216-476-9362        
CCOP - Columbus Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C     614-566-4475        
Mount Carmel Health - West Hospital Recruiting
Columbus, Ohio, United States, 43222
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Strecker Cancer Center at Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Hillcrest Cancer Center at Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose, MD     216-444-1712        
Lake/University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner, MD     216-844-5011        
Licking Memorial Cancer Care Program at Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Community Hospital of Springfield and Clark County Recruiting
Springfield, Ohio, United States, 45505
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Mount Carmel St. Ann's Cancer Center Recruiting
Westerville, Ohio, United States, 43081
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Genesis - Good Samaritan Hospital Recruiting
Zanesville, Ohio, United States, 43701
Contact: Clinical Trials Office - Genesis - Good Samaritan Hospital     740-454-5232        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel, MD     405-271-8787        
Cancer Care Associates - Saint Francis Campus Recruiting
Tulsa, Oklahoma, United States, 74136-1929
Contact: Robert S. Mannel, MD     405-271-8787        
United States, Oregon
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Recruiting
Portland, Oregon, United States, 97210
Contact: Clinical Trials Office - Legacy Good Samaritan Hospital & Com     503-413-1742        
Northwest Cancer Specialists at Rose Quarter Cancer Center Recruiting
Portland, Oregon, United States, 97227
Contact: William E. Winter, III     503-228-6509        
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M     215-481-2402        
St. Luke's Cancer Network at St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Sanjiv S. Agarwala, MD     610-954-2145        
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi     215-728-4790        
United States, Rhode Island
Women and Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I     401-274-1122        
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Luis A. Rojas-Espaillat     605-322-3000        
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0361
Contact: Clinical Trials Office - University of Texas Medical Branch     409-772-1950        
Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Tri A. Dinh     713-441-1010        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
United States, Utah
Sandra L. Maxwell Cancer Center Recruiting
Cedar City, Utah, United States, 84720
Contact: Ross E. Morgan, MD     801-408-5757        
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Ross E. Morgan, MD     801-408-5757        
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Clinical Trials Office - McKay-Dee Hospital Center     801-387-7426        
Utah Valley Regional Medical Center - Provo Recruiting
Provo, Utah, United States, 84604
Contact: Clinical Trials Office - Utah Valley Regional Medical Center -     801-357-7965        
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East     435-688-4167        
Utah Cancer Specialists at UCS Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Ross E. Morgan, MD     801-408-5757        
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Ross E. Morgan, MD     801-408-5757        
United States, Virginia
Naval Medical Center - Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Clinical Trials Office - Naval Medical Center - Portsmouth     757-953-5939        
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center     608-775-2385     cancerctr@gundluth.org    
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic     414-649-5717        
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C     414-805-4380        
Aurora Women's Pavilion of West Allis Memorial Hospital Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Peter Johnson, MD     262-549-6662        
Japan
Iwate Medical University Hospital Recruiting
Morioka, Iwate, Japan, 020-8505
Contact: Toru Sugiyama     81-19-651-5111        
Kagoshima City Hospital Recruiting
Kagoshima City, Kagoshima, Japan, 892-8580
Contact: Masayuki Hatae, MD     81-99-224-2101        
National Hospital Organization - Medical Center of Kure Recruiting
Kure, Japan, 737
Contact: Kazuhiro Takehara     81-82-322-3111        
Shikoku Cancer Center Recruiting
Matsuyama, Japan, 791-0280
Contact: Dina K. Rooney     81-89-932-1111        
Niigata University Medical and Dental Hospital Recruiting
Niigata City, Japan, 951-8520
Contact: Kenichi Tanaka     Not Available        
Tohoku University Graduate School of Medicine Recruiting
Sendai, Japan, 980-8574
Contact: Nobuo Yaegashi     81-22-274-1111        
Shizuoka Cancer Center Recruiting
Shizuoka City, Japan, 411-8777
Contact: Hiroshi Fuji     81-55-989-5222        
Korea, Republic of
National Cancer Center - Korea Recruiting
Goyang-si, Korea, Republic of, 410-769
Contact: Sang Y. Park     82-031-920-0001        
Dongsan Medical Center of Keimyung University Recruiting
Jung-Ku, Korea, Republic of, 700-712
Contact: Chi-Heum Cho     82-53-250-7114        
Catholic University of Korea College of Medicine Recruiting
Seoul, Korea, Republic of, 137-040
Contact: Jong-Sup Park     82-2-593-5141        
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Soon-Beom Kang     82-2-763-5110        
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae-Hoon Kim     82-2-2019-2114        
Korea Cancer Center Hospital Recruiting
Seoul, Korea, Republic of, 139-706
Contact: Beob-Jong Kim     82-2-9702-114        
Asan Medical Center - University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Young-Tak Kim     82-2-224-3210        
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Duk-Soo Bae     82-2-3410-0200, 0220        
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Hee-Sug Ryu     Not Available        
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sang Y. Ryu, MD Korea Cancer Center Hospital
Investigator: Wui-jin Koh, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01101451     History of Changes
Other Study ID Numbers: CDR0000670125, GOG-0263
Study First Received: April 9, 2010
Last Updated: February 9, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
 cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013