Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01414608
First received: August 10, 2011
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.


Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Chemotherapeutic Agent Toxicity
Cognitive Side Effects of Cancer Therapy
Psychological Impact of Cancer
Radiation Toxicity
Sexual Dysfunction and Infertility
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Drug: Cisplatin
Drug: Paclitaxel
Drug: Carboplatin
Radiation: External Beam Radiation Therapy
Radiation: Internal Radiation Therapy
Other: Quality-of-Life Assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
    Described with Kaplan-Meier curves and unadjusted logrank tests.


Secondary Outcome Measures:
  • Progression-free survival rate [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Rate of acute and long-term toxicities [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Patterns of disease recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Radiation protocol compliance [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Quality of life including psychosexual health [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: January 2012
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cisplatin, radiation therapy, brachytherapy)
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.
Drug: Cisplatin
Given IV
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation Therapy
  • External Beam RT
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Experimental: Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: Cisplatin
Given IV
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation Therapy
  • External Beam RT
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival rates. II. To determine acute and long-term toxicities. III. To determine patterns of disease recurrence. IV. To determine the association between radiation protocol compliance and outcomes.

V. To determine patient quality of life, including psycho-sexual health.

TERTIARY OBJECTIVES:

I. To determine the association between the results of a follow-up positron emission tomography (PET) scan performed 4-6 months post completion of chemoradiation and outcomes for all patients in the trial.

II. To determine the biological predictors of patients' outcomes based on translational laboratory studies of blood and tissue specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to pelvic or common iliac nodal involvement (yes vs no), requirement for extended-field radiotherapy treatment (yes vs no), International Federation of Gynecology and Obstetrics (FIGO) stage (IB/IIA vs IIB vs IIIB/IVA), age (< 60 years of age vs >= 60 years of age), and hospital/site. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.

ARM II: Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo baseline tumor biopsy and blood collection for future correlative studies.

Patients complete the European Organization for Research and Treatment of Cancer (EORTC) Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at baseline, during, and after completion of study treatment.

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

Inclusion Criteria:

  • Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:

    • Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
    • FIGO 2008 stage IB1 & node positive, IB2, II, IIIB, or IVA disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
  • White blood cells (WBC) >= 3.0 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelet count >= 100 x 10^9/L
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN
  • Creatinine =< ULN (Common Toxicity Criteria [CTC] Grade 0) OR calculated creatinine clearance (Cockcroft-Gault Formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
  • Written informed consent

Exclusion Criteria:

  • Any previous pelvic radiotherapy
  • Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT])
  • FIGO 2008 stage IIIA disease
  • Patients assessed at presentation as requiring interstitial brachytherapy treatment
  • Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
  • Previous chemotherapy for this tumor
  • Evidence of distant metastases
  • Prior diagnosis of Crohn disease or ulcerative colitis
  • Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] v. 4)
  • Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
  • Patients who are pregnant or lactating
  • Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
  • Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV) positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414608

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Warner K. Huh    205-934-0309      
Principal Investigator: Warner K. Huh         
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36688
Contact: Rodney P. Rocconi    251-445-9870    pfrancisco@usouthal.edu   
Principal Investigator: Rodney P. Rocconi         
United States, Arizona
Arizona Oncology Associates-Biltmore Cancer Center Recruiting
Phoenix, Arizona, United States, 85016
Contact: Michael G. Teneriello    512-427-9400      
Principal Investigator: Michael G. Teneriello         
Gynecologic Oncology Group of Arizona Recruiting
Phoenix, Arizona, United States, 85012
Contact: Kathleen N. Moore    405-271-8707    lreese@gog.org   
Principal Investigator: Kathleen N. Moore         
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kristin K. Zorn    501-686-8274      
Principal Investigator: Kristin K. Zorn         
United States, California
John Muir Medical Center-Concord Campus Recruiting
Concord, California, United States, 94520
Contact: Babak Edraki    925-674-2580      
Principal Investigator: Babak Edraki         
Kaiser Permanente, Fremont Recruiting
Fremont, California, United States, 94538
Contact: Tatjana Kolevska    626-564-3455      
Principal Investigator: Tatjana Kolevska         
Palo Alto Medical Foundation-Gynecologic Oncology Recruiting
Mountain View, California, United States, 94040
Contact: John K. Chan    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: John K. Chan         
Saint Joseph Hospital - Orange Recruiting
Orange, California, United States, 92868
Contact: Michael L. Berman    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Michael L. Berman         
University of California Medical Center At Irvine-Orange Campus Recruiting
Orange, California, United States, 92868
Contact: Krishnansu S. Tewari    714-456-6191    awallick@uci.edu   
Principal Investigator: Krishnansu S. Tewari         
Kaiser Permanente-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Tatjana Kolevska    626-564-3455      
Principal Investigator: Tatjana Kolevska         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Gary S. Leiserowitz    916-734-3089      
Principal Investigator: Gary S. Leiserowitz         
Olive View-University of California Los Angeles Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Christine H. Holschneider    888-798-0719      
Principal Investigator: Christine H. Holschneider         
Kaiser Permanente-Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Tatjana Kolevska    626-564-3455      
Principal Investigator: Tatjana Kolevska         
John Muir Medical Center Recruiting
Walnut Creek, California, United States, 94598
Contact: Babak Edraki    925-674-2580      
Principal Investigator: Babak Edraki         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan A. Davidson    720-848-0650      
Principal Investigator: Susan A. Davidson         
Penrose-Saint Francis Healthcare Active, not recruiting
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Angela S. Kueck    800-579-7822      
Principal Investigator: Angela S. Kueck         
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Peter E. Schwartz    203-785-5702      
Principal Investigator: Peter E. Schwartz         
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Mark E. Borowsky    302-733-6227      
Principal Investigator: Mark E. Borowsky         
United States, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Aaron H. Wolfson    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Aaron H. Wolfson         
UF Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Kathleen N. Moore    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Kathleen N. Moore         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: James V. Fiorica    941-917-2225      
Principal Investigator: James V. Fiorica         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sahar E. Rosenbaum    404-303-3355      
Principal Investigator: Sahar E. Rosenbaum         
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Joseph W. Shelton    404-489-9164      
Principal Investigator: Joseph W. Shelton         
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Joseph W. Shelton    404-489-9164      
Principal Investigator: Joseph W. Shelton         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Andrew E. Green    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Andrew E. Green         
Central Georgia Gynecologic Oncology Withdrawn
Macon, Georgia, United States, 31201
United States, Hawaii
Hawaii Minority Based CCOP Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Michael E. Carney    808-983-6090      
Principal Investigator: Michael E. Carney         
Kaiser Permanente Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Tatjana Kolevska    626-564-3455      
Principal Investigator: Tatjana Kolevska         
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Michael E. Carney    808-983-6090      
Principal Investigator: Michael E. Carney         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Thomas E. Lad    312-864-6000      
Principal Investigator: Thomas E. Lad         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric D. Donnelly    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Eric D. Donnelly         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Meaghan E. Tenney    773-834-7424      
Principal Investigator: Meaghan E. Tenney         
NorthShore University HealthSystem-Evanston Hospital Active, not recruiting
Evanston, Illinois, United States, 60201
Sudarshan K Sharma MD Limted-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma    630-856-6757      
Principal Investigator: Sudarshan K. Sharma         
Loyola University Medical Center Active, not recruiting
Maywood, Illinois, United States, 60153
United States, Indiana
Michiana Hematology Oncology PC-Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Kathleen N. Moore    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Kathleen N. Moore         
Indiana University/Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jeanne M. Schilder    317-274-2552      
Principal Investigator: Jeanne M. Schilder         
Saint Vincent Oncology Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton    317-338-2194      
Principal Investigator: Gregory P. Sutton         
Saint Joseph Regional Medical Center-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Kathleen N. Moore    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Kathleen N. Moore         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Julia A. Chapman    913-588-4709      
Principal Investigator: Julia A. Chapman         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Hope M. Cottrill    859-260-6425      
Principal Investigator: Hope M. Cottrill         
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Frederick R. Ueland    859-257-3379      
Principal Investigator: Frederick R. Ueland         
Norton Hospital Pavilion and Medical Campus Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mary E. Gordinier    502-629-2500      
Principal Investigator: Mary E. Gordinier         
United States, Louisiana
Louisiana State University Health Science Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Augusto C. Ochoa    504-568-2428    emede1@lsuhsc.edu   
Principal Investigator: Augusto C. Ochoa         
Ochsner Clinic CCOP Withdrawn
New Orleans, Louisiana, United States, 70121
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Richard C. Kline    888-562-4763      
Principal Investigator: Richard C. Kline         
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: William R. Robinson    504-988-6121      
Principal Investigator: William R. Robinson         
United States, Maine
Maine Medical Center-Bramhall Campus Recruiting
Portland, Maine, United States, 04102
Contact: Christopher J. Darus    207-885-7565      
Principal Investigator: Christopher J. Darus         
United States, Maryland
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gautam G. Rao    800-888-8823      
Principal Investigator: Gautam G. Rao         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Michael P. Stany    301-319-2100      
Principal Investigator: Michael P. Stany         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Tashanna K. Myers    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Tashanna K. Myers         
University of Massachusetts Memorial Health Care Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Susan L. Zweizig    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Susan L. Zweizig         
United States, Michigan
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Thomas E. Buekers    313-916-1784      
Principal Investigator: Thomas E. Buekers         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Robert T. Morris    313-576-9363      
Principal Investigator: Robert T. Morris         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
Grand Rapids Clinical Oncology Program Terminated
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Sunil Nagpal    269-373-7458      
Principal Investigator: Sunil Nagpal         
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Jayson B. Field    248-551-7695      
Principal Investigator: Jayson B. Field         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
United States, Minnesota
Mercy Hospital Withdrawn
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter A. Argenta    612-624-2620      
Principal Investigator: Peter A. Argenta         
Abbott-Northwestern Hospital Withdrawn
Minneapolis, Minnesota, United States, 55407
United Hospital Withdrawn
Saint Paul, Minnesota, United States, 55102
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen    601-815-6700      
Principal Investigator: James T. Thigpen         
United States, Missouri
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
United States, Montana
Billings Clinic Cancer Center Active, not recruiting
Billings, Montana, United States, 59107
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris    402-354-7939    kathryn.bartz@nmhs.org   
Principal Investigator: Peter C. Morris         
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Kerry J. Rodabaugh    800-999-5465      
Principal Investigator: Kerry J. Rodabaugh         
University of Nebraska Medical Center Terminated
Omaha, Nebraska, United States, 68198
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    702-851-4672      
Principal Investigator: Nicola M. Spirtos         
United States, New Jersey
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: David P. Warshal    856-325-6757      
Principal Investigator: David P. Warshal         
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Donna T. McNamara    201-996-2879      
Principal Investigator: Donna T. McNamara         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Yana P. Goldberg    973-971-5900      
Principal Investigator: Yana P. Goldberg         
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Withdrawn
Mount Holly, New Jersey, United States, 08060
Jersey Shore Medical Center Active, not recruiting
Neptune, New Jersey, United States, 07753
Rutgers Cancer Institute of New Jersey Terminated
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Kathleen N. Moore    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Kathleen N. Moore         
Southwest Gynecologic Oncology Associates Inc Active, not recruiting
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Women's Cancer Care Associates LLC Recruiting
Albany, New York, United States, 12208
Contact: Thomas P. Morrissey    518-458-1390      
Principal Investigator: Thomas P. Morrissey         
Montefiore Medical Center-Einstein Campus Recruiting
Bronx, New York, United States, 10461
Contact: Mark H. Einstein    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Mark H. Einstein         
State University of New York Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Ovadia Abulafia    718-270-8216    sima.terebelo@downstate.edu   
Principal Investigator: Ovadia Abulafia         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Peter J. Frederick    877-275-7724      
Principal Investigator: Peter J. Frederick         
New York Hospital Medical Center of Queens Terminated
Fresh Meadows, New York, United States, 11365
Queens Hospital Center Terminated
Jamaica, New York, United States, 11432
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Veena S. John    516-562-3467      
Principal Investigator: Veena S. John         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Jeannine A. Villella    866-946-8476      
Principal Investigator: Jeannine A. Villella         
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Veena S. John    516-562-3467      
Principal Investigator: Veena S. John         
North Shore-LIJ Health System/Center for Advanced Medicine Recruiting
New Hyde Park, New York, United States, 11040
Contact: Veena S. John    516-562-3467      
Principal Investigator: Veena S. John         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario M. Leitao    212-639-7202      
Principal Investigator: Mario M. Leitao         
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Stephanie V. Blank    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Stephanie V. Blank         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Michael L. Pearl    800-862-2215      
Principal Investigator: Michael L. Pearl         
United States, North Carolina
Cone Health Cancer Center at Alamance Regional Recruiting
Burlington, North Carolina, United States, 27216
Contact: Janak K. Choksi    336-538-7725      
Principal Investigator: Janak K. Choksi         
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Robert V. Higgins    704-355-2884      
Principal Investigator: Robert V. Higgins         
Carolinas Medical Center - Northeast Recruiting
Concord, North Carolina, United States, 28025
Contact: Brigitte E. Miller    704-403-1520      
Principal Investigator: Brigitte E. Miller         
New Hanover Regional Medical Center Terminated
Wilmington, North Carolina, United States, 28401
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
University of Cincinnati Active, not recruiting
Cincinnati, Ohio, United States, 45267
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Case Western Reserve University Withdrawn
Cleveland, Ohio, United States, 44106
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: David M. O'Malley         
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Howard M. Gross    937-775-1350      
Principal Investigator: Howard M. Gross         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Howard M. Gross    937-775-1350      
Principal Investigator: Howard M. Gross         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Lake University Ireland Cancer Center Withdrawn
Mentor, Ohio, United States, 44060
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Parviz Hanjani    215-481-2402      
Principal Investigator: Parviz Hanjani         
Saint Luke's University Hospital-Bethlehem Campus Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Nicholas P. Taylor    610-954-3582    infolink@slhn.org   
Principal Investigator: Nicholas P. Taylor         
Gynecologic Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Philip J. DiSaia    215-854-0770    lreese@gog.org   
Principal Investigator: Kathleen N. Moore         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Pramila R. Anne    215-955-6084      
Principal Investigator: Pramila R. Anne         
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robert A. Burger    215-746-7406      
Principal Investigator: Robert A. Burger         
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dwight E. Heron    412-647-8073      
Principal Investigator: Dwight E. Heron         
UPMC-Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dwight E. Heron    412-647-8073      
Principal Investigator: Dwight E. Heron         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Bernice L. Robinson-Bennett    610-988-9323      
Principal Investigator: Bernice L. Robinson-Bennett         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Paul A. DiSilvestro    401-274-1122      
Principal Investigator: Paul A. DiSilvestro         
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jennifer L. Young Pierce    843-792-9321      
Principal Investigator: Jennifer L. Young Pierce         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Upstate Carolina CCOP Terminated
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Black Hills Obstetrics and Gynecology Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Helen L. Frederickson    605-343-9224      
Principal Investigator: Helen L. Frederickson         
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Helen L. Frederickson    605-343-9224      
Principal Investigator: Helen L. Frederickson         
United States, Texas
Texas Oncology - Central Austin Cancer Center Recruiting
Austin, Texas, United States, 78731
Contact: Michael G. Teneriello    512-427-9400      
Principal Investigator: Michael G. Teneriello         
Texas Oncology - South Austin Cancer Center Recruiting
Austin, Texas, United States, 78745
Contact: Michael G. Teneriello    512-427-9400      
Principal Investigator: Michael G. Teneriello         
Texas Oncology-Austin Midtown Recruiting
Austin, Texas, United States, 78705
Contact: Michael G. Teneriello    512-427-9400      
Principal Investigator: Michael G. Teneriello         
Texas Oncology Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Michael G. Teneriello    512-427-9400      
Principal Investigator: Michael G. Teneriello         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
Texas Oncology Fort Worth at 12th Avenue Recruiting
Fort Worth, Texas, United States, 76104
Contact: Michael G. Teneriello    512-427-9400      
Principal Investigator: Michael G. Teneriello         
University of Texas Medical Branch at Galveston Active, not recruiting
Galveston, Texas, United States, 77555-0565
Memorial Hermann Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Joseph A. Lucci    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Joseph A. Lucci         
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lois M. Ramondetta       lramonde@mdanderson.org   
Principal Investigator: Lois M. Ramondetta         
Lyndon Baines Johnson General Hospital Recruiting
Houston, Texas, United States, 77026-1967
Contact: Lois M. Ramondetta    713-792-3245      
Principal Investigator: Lois M. Ramondetta         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Matthew M. Poppe    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: Matthew M. Poppe         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Utah Cancer Specialists-Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84106
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Susan C. Modesitt    434-243-6143      
Principal Investigator: Susan C. Modesitt         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Weldon E. Chafe    804-628-1939      
Principal Investigator: Weldon E. Chafe         
Carilion Clinic Gynecological Oncology Recruiting
Roanoke, Virginia, United States, 24016
Contact: Janet L. Osborne    540-985-8510      
Principal Investigator: Janet L. Osborne         
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: Ali Mahdavi    414-649-5717      
Principal Investigator: Ali Mahdavi         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kristin A. Bradley    877-405-6866      
Principal Investigator: Kristin A. Bradley         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Ali Mahdavi    414-649-5717      
Principal Investigator: Ali Mahdavi         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: William H. Bradley    414-805-4380      
Principal Investigator: William H. Bradley         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Ali Mahdavi    414-649-5717      
Principal Investigator: Ali Mahdavi         
Aurora West Allis Medical Center Active, not recruiting
West Allis, Wisconsin, United States, 53227
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Lorraine (Laurie) M. Elit    905-387-9495      
Principal Investigator: Lorraine (Laurie) M. Elit         
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David P. D'Souza    519-685-8600      
Principal Investigator: David P. D'Souza         
University Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anthony W. Fyles    416-946-4501    clinical.trials@uhn.on.ca   
Principal Investigator: Anthony W. Fyles         
Canada, Quebec
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Maroie Barkati    514-890-8000ext23611    sylvie.beaudoin.chum@ssss.gouv.qc.ca   
Principal Investigator: Maroie Barkati         
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Evgeny Sadikov    306-766-2213      
Principal Investigator: Evgeny Sadikov         
Saudi Arabia
King Faisal Specialist Hospital and Research Centre Active, not recruiting
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Kathleen Moore Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01414608     History of Changes
Other Study ID Numbers: ANZGOG-0902/GOG-0274/RTOG-1174, NCI-2011-02978, CDR0000706698, GOG-0274, RTOG-1174, ANZGOG-0902, ANZGOG-0902/GOG-0274/RTOG-1174, ANZGOG-0902-GOG-0274, U10CA027469
Study First Received: August 10, 2011
Last Updated: December 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Carboplatin
Cisplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on March 01, 2015