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Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

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ClinicalTrials.gov Identifier: NCT01595061
Recruitment Status : Recruiting
First Posted : May 9, 2012
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Stage IIIA Vulvar Cancer AJCC v7 Stage IIIB Vulvar Cancer AJCC v7 Stage IIIC Vulvar Cancer AJCC v7 Stage IVA Vulvar Cancer AJCC v7 Vulvar Squamous Cell Carcinoma Drug: Cisplatin Drug: Gemcitabine Hydrochloride Radiation: Intensity-Modulated Radiation Therapy Procedure: Therapeutic Conventional Surgery Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

SECONDARY OBJECTIVES:

I. To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete clinical response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

II. To determine the vulvar progression-free survival and groin progression-free survival in women treated with cisplatin, gemcitabine and IMRT for locally advanced vulvar carcinoma.

III. To determine the toxicity and surgical morbidity of the combined modality approach of cisplatin, gemcitabine and IMRT followed by reduced-scope surgery for the treatment of locally-advanced vulvar carcinoma.

OUTLINE:

Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)
Actual Study Start Date : July 2, 2012
Estimated Primary Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer

Arm Intervention/treatment
Experimental: Treatment (IMRT, gemcitabine, cisplatin, surgery)
Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • Gemzar
  • LY-188011
  • LY188011

Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Procedure: Therapeutic Conventional Surgery
Undergo local core biopsy or surgical excision




Primary Outcome Measures :
  1. Complete pathologic response evaluated as the frequency of complete clinical and pathologic response after primary therapy [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Complete clinical response, defined as no clinical/radiographic evidence of primary disease (vulvar or groin) following chemo-radiation therapy [ Time Frame: 6 weeks ]
  2. Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0 [ Time Frame: Up to 5 years ]
    Maximum grade of treatment related adverse effects will be tabulated based CTCAE v 4.0 grading system.

  3. Progression-free survival (PFS) [ Time Frame: From start of protocol therapy to date of reappearance of disease or date of last contact, assessed up to 5 years ]
    Product-limit estimates according to the method of Kaplan and Meier will be calculated to assess duration of PFS among the entire study cohort and by response status.

  4. Site(s) of disease recurrence/relapse [ Time Frame: Up to 5 years ]
    Site(s) of first disease recurrence will be classified as: local (vagina or vulva), loco-regional (within the pelvic) or distant and tabulated by response status.

  5. Overall survival (OS) [ Time Frame: From start of protocol therapy to death or, for living patients, the date of last contact, assessed up to 5 years ]
    Product-limit estimates according to the method of Kaplan and Meier will be calculated to assess duration of OS among the entire study cohort and by response status.

  6. Treatment compliance, including treatment span, incidence and duration of treatment delay, reasons for delays, chemotherapy dose, radiation dose and reasons for dose level reductions [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva
  • Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelets >= 100,000/mcl
  • Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min
  • Bilirubin =< 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
  • Alkaline phosphatase =< 3 x ULN
  • Patients judged capable of tolerating a radical course of chemoradiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients with a GOG performance status of 0, 1, or 2

Exclusion Criteria:

  • Patients with recurrent carcinoma of the vulva regardless of previous treatment
  • Patients who have received prior pelvic radiation or cytotoxic chemotherapy
  • Patients with vulvar melanomas or sarcomas
  • Patients with circumstances that will not permit completion of the study or the required follow-up
  • Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595061


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Locations
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United States, Alaska
Anchorage Associates in Radiation Medicine Recruiting
Anchorage, Alaska, United States, 98508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
Anchorage Radiation Therapy Center Recruiting
Anchorage, Alaska, United States, 99504
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
Alaska Breast Care and Surgery LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
Alaska Oncology and Hematology LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
Alaska Women's Cancer Care Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Dan S. Zuckerman         
Anchorage Oncology Centre Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Dan S. Zuckerman         
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
Contact: Site Public Contact    818-847-4793    Madonna.Johnson@providence.org   
Principal Investigator: Dan S. Zuckerman         
UC Irvine Health/Chao Family Comprehensive Cancer Center Suspended
Orange, California, United States, 92868
United States, Connecticut
Hartford Hospital Active, not recruiting
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut Active, not recruiting
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Site Public Contact    302-645-3770    Dmiskin@Beebehealthcare.org   
Principal Investigator: Mark E. Borowsky         
Christiana Gynecologic Oncology LLC Suspended
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Mark E. Borowsky         
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Mark E. Borowsky         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Mark E. Borowsky         
Regional Hematology and Oncology PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Mark E. Borowsky         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Mark E. Borowsky         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Site Public Contact    302-645-3100    Dmiskin@Beebehealthcare.org   
Principal Investigator: Mark E. Borowsky         
Nanticoke Memorial Hospital Recruiting
Seaford, Delaware, United States, 19973
Contact: Site Public Contact    302-645-3100    Dmiskin@Beebehealthcare.org   
Principal Investigator: Mark E. Borowsky         
Christiana Care Health System-Wilmington Hospital Recruiting
Wilmington, Delaware, United States, 19801
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Mark E. Borowsky         
United States, Georgia
Augusta University Medical Center Suspended
Augusta, Georgia, United States, 30912
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Active, not recruiting
Savannah, Georgia, United States, 31405
United States, Hawaii
The Cancer Center of Hawaii-Pali Momi Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Site Public Contact    808-678-9000      
Principal Investigator: Michael E. Carney         
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Michael E. Carney         
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-586-2979      
Principal Investigator: Michael E. Carney         
The Cancer Center of Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Site Public Contact    808-547-6881      
Principal Investigator: Michael E. Carney         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Michael E. Carney         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Benjamin B. Bridges         
Saint Luke's Mountain States Tumor Institute - Fruitland Recruiting
Fruitland, Idaho, United States, 83619
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Benjamin B. Bridges         
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Benjamin B. Bridges         
Saint Luke's Mountain States Tumor Institute - Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Benjamin B. Bridges         
Saint Luke's Mountain States Tumor Institute-Twin Falls Recruiting
Twin Falls, Idaho, United States, 83301
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Benjamin B. Bridges         
United States, Illinois
Rush - Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Site Public Contact    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
Saint Joseph Medical Center Suspended
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Memorial Hospital of Carbondale Recruiting
Carbondale, Illinois, United States, 62902
Contact: Site Public Contact    618-457-5200    clinical.research@sih.net   
Principal Investigator: James L. Wade         
SIH Cancer Institute Recruiting
Carterville, Illinois, United States, 62918
Contact: Site Public Contact    618-985-3333    clinical.research@sih.net   
Principal Investigator: James L. Wade         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
University of Chicago Comprehensive Cancer Center Suspended
Chicago, Illinois, United States, 60637
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740      
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Western Illinois Cancer Treatment Center Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-344-2831      
Principal Investigator: James L. Wade         
Northwestern Medicine Cancer Center Delnor Suspended
Geneva, Illinois, United States, 60134
Sudarshan K Sharma MD Limited-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Site Public Contact    630-856-6757      
Principal Investigator: Sudarshan K. Sharma         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
Good Samaritan Regional Health Center Suspended
Mount Vernon, Illinois, United States, 62864
UC Comprehensive Cancer Center at Silver Cross Suspended
New Lenox, Illinois, United States, 60451
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Radiation Oncology of Northern Illinois Suspended
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Valley Radiation Oncology Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    815-664-4141      
Principal Investigator: James L. Wade         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: James L. Wade         
Central Illinois Hematology Oncology Center Suspended
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: James L. Wade         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: James L. Wade         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: James L. Wade         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Southwest Illinois Health Services LLP Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    618-236-1000    lynns@thecancercenter.com   
Principal Investigator: James L. Wade         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
Rush-Copley Healthcare Center Recruiting
Yorkville, Illinois, United States, 60560
Contact: Site Public Contact    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Maria T. Grosse-Perdekamp         
United States, Indiana
Parkview Hospital Randallia Active, not recruiting
Fort Wayne, Indiana, United States, 46805
Parkview Regional Medical Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Site Public Contact    877-784-4673      
Principal Investigator: Iwona Podzielinski         
Indiana University/Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Jeanne M. Schilder         
United States, Kentucky
Saint Elizabeth Medical Center South Active, not recruiting
Edgewood, Kentucky, United States, 41017
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Frederick R. Ueland         
United States, Louisiana
Woman's Hospital Suspended
Baton Rouge, Louisiana, United States, 70817
Ochsner Baptist Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Katrina S. Wade         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Katrina S. Wade         
United States, Maryland
Union Hospital of Cecil County Suspended
Elkton, Maryland, United States, 21921
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Neil S. Horowitz         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Neil S. Horowitz         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Neil S. Horowitz         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Site Public Contact    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Tashanna K. Myers         
United States, Michigan
Wayne State University/Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Weisberg Cancer Treatment Center Active, not recruiting
Farmington Hills, Michigan, United States, 48334
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Sunil Nagpal         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Sunil Nagpal         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49048
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Sunil Nagpal         
United States, Minnesota
Sanford Joe Lueken Cancer Center Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Site Public Contact    218-333-5000      
Principal Investigator: Maria C. Bell         
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: Site Public Contact    314-996-5569      
Principal Investigator: James L. Wade         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: James L. Wade         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-651-5550      
Principal Investigator: James L. Wade         
Capital Region Southwest Campus Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Site Public Contact    573-632-4814    swooden@mail.crmc.org   
Principal Investigator: James L. Wade         
Mercy Hospital Joplin Suspended
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Mercy Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Saint Louis Cancer and Breast Institute-South City Suspended
Saint Louis, Missouri, United States, 63109
Barnes-Jewish Hospital Active, not recruiting
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: James L. Wade         
Mercy Hospital Saint Louis Suspended
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: Site Public Contact    314-996-5569      
Principal Investigator: James L. Wade         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: Site Public Contact    314-996-5569      
Principal Investigator: James L. Wade         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: Site Public Contact    314-996-5569      
Principal Investigator: James L. Wade         
United States, Montana
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Site Public Contact    406-327-3118    amy.hanneman@providence.org   
Principal Investigator: Dan S. Zuckerman         
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Nicola M. Spirtos         
United States, New Jersey
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: Site Public Contact    856-325-6757      
Principal Investigator: David P. Warshal         
MD Anderson Cancer Center at Cooper-Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Site Public Contact    856-325-6757      
Principal Investigator: David P. Warshal         
United States, New York
Women's Cancer Care Associates LLC Active, not recruiting
Albany, New York, United States, 12208
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute Suspended
Charlotte, North Carolina, United States, 28203
AdventHealth Hendersonville Suspended
Hendersonville, North Carolina, United States, 28792
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Samuel S. Lentz         
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Site Public Contact    701-323-5760    tamara.fischer@sanfordhealth.org   
Principal Investigator: Maria C. Bell         
Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-234-6161      
Principal Investigator: Maria C. Bell         
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    800-437-4010      
Principal Investigator: Maria C. Bell         
Sanford Clinic North-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Active, not recruiting
Akron, Ohio, United States, 44304
UHHS-Chagrin Highlands Medical Center Active, not recruiting
Beachwood, Ohio, United States, 44122
University of Cincinnati/Barrett Cancer Center Suspended
Cincinnati, Ohio, United States, 45219
Case Western Reserve University Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Peter G. Rose         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Peter G. Rose         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Site Public Contact    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Floor Backes         
Grandview Hospital Suspended
Dayton, Ohio, United States, 45405
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Peter G. Rose         
UH Seidman Cancer Center at Lake Health Mentor Campus Active, not recruiting
Mentor, Ohio, United States, 44060
UHHS-Westlake Medical Center Active, not recruiting
Westlake, Ohio, United States, 44145
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Katherine M. Moxley         
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Site Public Contact    918-505-3200      
Principal Investigator: Katherine M. Moxley         
United States, Oregon
Saint Charles Health System Recruiting
Bend, Oregon, United States, 97701
Contact: Site Public Contact    541-706-2909    nosall@stcharleshealthcare.org   
Principal Investigator: Dan S. Zuckerman         
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Oncology and Hematology Care Southeast Recruiting
Clackamas, Oregon, United States, 97015
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Bay Area Hospital Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Site Public Contact    541-269-8392    cherie.cox@bayareahospital.org   
Principal Investigator: Dan S. Zuckerman         
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Saint Charles Health System-Redmond Recruiting
Redmond, Oregon, United States, 97756
Contact: Site Public Contact    541-706-2909      
Principal Investigator: Dan S. Zuckerman         
United States, Pennsylvania
Abington Memorial Hospital Suspended
Abington, Pennsylvania, United States, 19001
Temple University Hospital Suspended
Philadelphia, Pennsylvania, United States, 19140
Abington Memorial Hospital-Asplundh Cancer Pavilion Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Site Public Contact    215-481-2402      
Principal Investigator: Mark S. Shahin         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Site Public Contact    401-274-1122      
Principal Investigator: Paul A. DiSilvestro         
United States, South Carolina
AnMed Health Cancer Center Suspended
Anderson, South Carolina, United States, 29621
Greenville Health System Cancer Institute-Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Gibbs Cancer Center-Gaffney Suspended
Gaffney, South Carolina, United States, 29341
Greenville Health System Cancer Institute-Andrews Suspended
Greenville, South Carolina, United States, 29601
Saint Francis Hospital Suspended
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: James E. Hunter         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: James E. Hunter         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey W. Elder         
United States, South Dakota
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Site Public Contact    605-312-3320      
Principal Investigator: Maria C. Bell         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Maria C. Bell         
United States, Texas
Parkland Memorial Hospital Suspended
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas Suspended
Dallas, Texas, United States, 75390
Memorial Hermann Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-792-3245      
Principal Investigator: Joseph A. Lucci         
United States, Washington
Providence Regional Cancer System-Aberdeen Recruiting
Aberdeen, Washington, United States, 98520
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Dan S. Zuckerman         
PeaceHealth Saint Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Site Public Contact    360-715-4133    mjohnson9@peacehealth.org   
Principal Investigator: Dan S. Zuckerman         
Providence Regional Cancer System-Centralia Recruiting
Centralia, Washington, United States, 98531
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Dan S. Zuckerman         
Swedish Medical Center-Edmonds Recruiting
Edmonds, Washington, United States, 98026
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Site Public Contact    425-261-3529    marilyn.birchman@providence.org   
Principal Investigator: Dan S. Zuckerman         
Swedish Cancer Institute-Issaquah Recruiting
Issaquah, Washington, United States, 98029
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Site Public Contact    509-783-4637    research@kadlecmed.org   
Principal Investigator: Dan S. Zuckerman         
Providence Regional Cancer System-Lacey Recruiting
Lacey, Washington, United States, 98503
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Dan S. Zuckerman         
PeaceHealth Saint John Medical Center Recruiting
Longview, Washington, United States, 98632
Contact: Site Public Contact    360-514-2016    kmakin-bond@peacehealth.org   
Principal Investigator: Dan S. Zuckerman         
Pacific Gynecology Specialists Recruiting
Seattle, Washington, United States, 98104
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
Swedish Medical Center-Ballard Campus Recruiting
Seattle, Washington, United States, 98107
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
Kaiser Permanente Washington Recruiting
Seattle, Washington, United States, 98112
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
Swedish Medical Center-First Hill Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
Swedish Medical Center-Cherry Hill Recruiting
Seattle, Washington, United States, 98122-5711
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Dan S. Zuckerman         
PeaceHealth United General Medical Center Recruiting
Sedro-Woolley, Washington, United States, 98284
Contact: Site Public Contact    360-788-8240      
Principal Investigator: Dan S. Zuckerman         
Providence Regional Cancer System-Shelton Recruiting
Shelton, Washington, United States, 98584
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Dan S. Zuckerman         
Rockwood Clinic Cancer Treatment Center-Valley Active, not recruiting
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown Active, not recruiting
Spokane, Washington, United States, 99204
Rockwood North Cancer Treatment Center Active, not recruiting
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Site Public Contact    360-514-3940    kmakin-bond@peacehealth.org   
Principal Investigator: Dan S. Zuckerman         
Providence Saint Mary Regional Cancer Center Recruiting
Walla Walla, Washington, United States, 99362
Contact: Site Public Contact    509-897-5993    Cheryl.Dodd@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Regional Cancer System-Yelm Recruiting
Yelm, Washington, United States, 98597
Contact: Site Public Contact    360-412-8958    deidre.dillon@providence.org   
Principal Investigator: Dan S. Zuckerman         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Lisa M. Barroilhet         
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Neil S Horowitz NRG Oncology

Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01595061     History of Changes
Other Study ID Numbers: GOG-0279
NCI-2012-01964 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000732793
GOG-0279 ( Other Identifier: NRG Oncology )
GOG-0279 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Vulvar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female
Cisplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs