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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00262821
Other study ID # NCI-2009-00591
Secondary ID NCI-2009-00591CA
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 2006
Est. completion date August 2010

Study information

Verified date July 2019
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.


Description:

PRIMARY OBJECTIVE:

I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine.

SECONDARY OBJECTIVES:

I. Compare overall survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients.

TERTIARY OBJECTIVES:

I. Correlate study treatment with tumor expression of carbonic anhydrase IX (CA-IX) and recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

II. Correlate expression of CA-IX, hypoxia inducible factor-1α, CD-31, thrombospondin-1, CD-105, or vascular endothelial growth factor (VEGF) in primary tumor tissue with recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

III. Correlate pre-treatment and/or post-treatment serum concentrations of angiogenic markers including angiogenin or VEGF with recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

IV. Correlate various combinations of biological markers of hypoxia and angiogenesis with recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

V. Correlate levels of individual biological markers of hypoxia or angiogenesis with clinicopathological characteristics including tumor size, histologic subtype, FIGO stage, depth of invasion, pelvic node status, site of recurrence, and hemoglobin level as well as patient, age, race and performance status in patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to FIGO stage of disease (IB2 vs IIA vs IIB vs IIIB vs IVA), brachytherapy method (low-dose rate vs high-dose rate), surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin IV over 30-60 minutes once weekly on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)* brachytherapy once weekly in weeks 4-8 and 3-5 days of parametrial boost radiotherapy** beginning after the first brachytherapy implant. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29. Patients also undergo radiotherapy and brachytherapy as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment within 8 weeks.

NOTE: ** Patients may receive a parametrial boost at the discretion of the treating radiation oncologist.

After completion of study treatment, patients are followed for at least 5 years.


Other known NCT identifiers
  • NCT00704873

Recruitment information / eligibility

Status Terminated
Enrollment 402
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix

- Stage IB2, IIA, IIB, IIIB, or IVA disease

- Stage IIA tumors must be > 4 cm

- Primary, untreated disease

- Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy

- Must have been adequately clinically staged

- Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy

- No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement)

- No carcinoma of the cervical stump

- Performance status - GOG 0-3

- Absolute neutrophil count = 1,500/mm^3

- Platelet count = 100,000/mm^3

- Bilirubin = 1.5 times upper limit of normal (ULN)

- SGOT = 3 times ULN

- Alkaline phosphatase = 3 times ULN

- Creatinine = ULN or calculated creatinine clearance = 60mL/min

- No New York Heart Association class III-IV heart failure

- No history of myocardial infarction

- No unstable angina

- No uncontrolled hypertension

- No pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No septicemia or severe infection

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy

- No prior coronary artery bypass surgery

- No prior cancer therapy that would preclude study treatment

- No concurrent angina medication

- No concurrent intensity-modulated radiotherapy

Study Design


Intervention

Drug:
cisplatin
Given IV
tirapazamine
Given IV

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada CHUM - Hopital Notre-Dame Montreal Quebec
Canada CHUQ - Pavilion Hotel-Dieu de Quebec Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Health Sciences North Sudbury Ontario
Canada BCCA-Fraser Valley Cancer Centre Surrey British Columbia
Canada Thunder Bay Regional Health Science Centre Thunder Bay Ontario
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada BCCA-Vancouver Cancer Centre Vancouver British Columbia
United States Pali Momi Medical Center 'Aiea Hawaii
United States Abington Memorial Hospital Abington Pennsylvania
United States Akron General Medical Center Akron Ohio
United States Women's Cancer Care Associates LLC Albany New York
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital Allentown Pennsylvania
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States American Fork Hospital American Fork Utah
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States Providence Alaska Medical Center Anchorage Alaska
United States Northern Virginia Pelvic Surgery Associates Annandale Virginia
United States Hospital District Sixth of Harper County Anthony Kansas
United States Hope Women's Cancer Centers-Asheville Asheville North Carolina
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Georgia Regents University Augusta Georgia
United States Colorado Gynecologic Oncology Group Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States Eastern Maine Medical Center Bangor Maine
United States Bronson Battle Creek Battle Creek Michigan
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies PC Billings Montana
United States Montana Cancer Consortium CCOP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States University of Alabama at Birmingham Birmingham Alabama
United States Bismarck Cancer Center Bismarck North Dakota
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Joseph Medical Center Bloomington Illinois
United States Island Gynecologic Oncology Brightwaters New York
United States Montefiore Medical Center-Weiler Division Bronx New York
United States State University of New York Downstate Medical Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care-Medical Center Burlington Vermont
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Graham Hospital Association Canton Illinois
United States East Bay Radiation Oncology Center Castro Valley California
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Charlottesville Virginia
United States Chattanooga Gynecological Oncology Chattanooga Tennessee
United States Chattanooga's Program in Women's Oncology Chattanooga Tennessee
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Chicago Illinois
United States University of Illinois Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Memorial Hospital Colorado Springs Colorado Springs Colorado
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Health Center Dayton Ohio
United States Dekalb Medical Center Decatur Georgia
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa Oncology Research Association CCOP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States City of Hope Medical Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Saint Elizabeth Medical Center South Edgewood Kentucky
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Saint Francis Hospital Evanston Illinois
United States Highlands Oncology Group PA - Fayetteville Fayetteville Arkansas
United States Washington Regional Medical Center - Fayetteville Fayetteville Arkansas
United States Florida Gynecologic Oncology Fort Myers Florida
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States University of Texas Medical Branch at Galveston Galveston Texas
United States Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States Gynecologic Oncology of West Michigan PLLC Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Spectrum Health-Blodgett Campus Grand Rapids Michigan
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Green Bay Wisconsin
United States Hartford Hospital Hartford Connecticut
United States Hawaii Minority Based CCOP Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Honolulu Hawaii
United States M D Anderson Cancer Center Houston Texas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Centerpoint Medical Center LLC Independence Missouri
United States Gynecologic Oncology of Indiana Indianapolis Indiana
United States Indiana University Medical Center Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States Queens Hospital Center Jamaica New York
United States East Tennessee State University Johnson City Tennessee
United States Joliet Oncology-Hematology Associates Limited Joliet Illinois
United States Providence Medical Center Kansas City Kansas
United States Radiation Oncology Practice Corporation - North Kansas City Missouri
United States Radiation Oncology Practice Corporation South Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Good Samaritan Hospital Kearney Nebraska
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Community Howard Regional Health Kokomo Indiana
United States IU Health La Porte Hospital La Porte Indiana
United States Lancaster General Hospital Lancaster Pennsylvania
United States Doctor's Hospital of Laredo Laredo Texas
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Logan Regional Hospital Logan Utah
United States Jonsson Comprehensive Cancer Center Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Texas Tech University Health Sciences Center Lubbock Texas
United States North Shore University Hospital Manhasset New York
United States North Shore-LIJ Health System CCOP Manhasset New York
United States Wellstar Kennestone Hospital Marietta Georgia
United States Bay Area Medical Center Marinette Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Lake University Ireland Cancer Center Mentor Ohio
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Orange Regional Medical Center Middletown New York
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Mobile Infirmary Medical Center Mobile Alabama
United States Mountainside Hospital Montclair New Jersey
United States Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey
United States Cottonwood Hospital Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States Meharry Medical College Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Jersey Shore Medical Center Neptune New Jersey
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States North Shore-LIJ Health System/Center for Advanced Medicine New Hyde Park New York
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Memorial Sloan-Kettering Cancer Center New York New York
United States New York University Langone Medical Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States UMDNJ - New Jersey Medical School Newark New Jersey
United States Bon Secours Mary Immaculate Hospital Newport News Virginia
United States Cancer Center of Kansas - Newton Newton Kansas
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Southwest VA Regional Cancer Center Norton Virginia
United States Bay Area Tumor Institute CCOP Oakland California
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States University of California Medical Center At Irvine-Orange Campus Orange California
United States UF Cancer Center at Orlando Health Orlando Florida
United States Radiation Oncology Practice Corporation Southwest Overland Park Kansas
United States Advocate Lutheran General Hospital. Park Ridge Illinois
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Peoria Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Valley Radiation Oncology Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Banner Good Samaritan Medical Center Phoenix Arizona
United States Western Regional CCOP Phoenix Arizona
United States Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania
United States Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Pomona Valley Hospital Medical Center Pomona California
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Women and Infants Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Good Samaritan Community Hospital Puyallup Washington
United States Black Hills Obstetrics and Gynecology Rapid City South Dakota
United States Center of Hope at Renown Medical Center Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Virginia Commonwealth University Richmond Virginia
United States Carilion Clinic Gynecological Oncology Roanoke Virginia
United States Mayo Clinic Rochester Minnesota
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Lakeland Hospital Saint Joseph Michigan
United States Center for Cancer Care and Research Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint John's Mercy Medical Center Saint Louis Missouri
United States Saint Louis University Hospital Saint Louis Missouri
United States Salem Hospital Salem Oregon
United States Cancer Center of Kansas - Salina Salina Kansas
United States Intermountain Health Care Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Memorial Health University Medical Center Savannah Georgia
United States Hematology and Oncology Associates of North East Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States University of Washington Medical Center Seattle Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana
United States Siouxland Hematology Oncology Associates Sioux City Iowa
United States Memorial Hospital of South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Providence Hospital Southfield Michigan
United States Saint Margaret's Hospital Spring Valley Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield Missouri
United States Stanford University Hospitals and Clinics Stanford California
United States Stony Brook University Medical Center Stony Brook New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States State University of New York Upstate Medical University Syracuse New York
United States Multicare Health System Tacoma Washington
United States Northwest CCOP Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Tacoma General Hospital Tacoma Washington
United States Community Medical Center Toms River New Jersey
United States Munson Medical Center Traverse City Michigan
United States Cancer Care Associates-Midtown Tulsa Oklahoma
United States Tulsa Cancer Institute Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States Carle Clinic-Urbana Main Urbana Illinois
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Maui Memorial Medical Center Wailuku Hawaii
United States Washington Hospital Center Washington District of Columbia
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Good Samaritan Hospital Medical Center West Islip New York
United States Reading Hospital West Reading Pennsylvania
United States Wheeling Hospital Wheeling West Virginia
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Main Office Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Wichita CCOP Wichita Kansas
United States New Hanover Regional Medical Center Wilmington North Carolina
United States Wilson Medical Center Wilson North Carolina
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States University of Massachusetts Medical School Worcester Massachusetts
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States Metro Health Hospital Wyoming Michigan

Sponsors (3)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Gynecologic Oncology Group, NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival - Percentage of Patients Alive and Progression Free Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact. From study entry until first disease progression, death or date of last contact, up to 6 years
Secondary Overall Survival The observed length of life from entry into the study to death or date of last contact. From study entry to death or last contact, up to 6 years
Secondary Adverse Events (Grade 3 or Higher) During Treatment Period Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0. All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported
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