Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis
Verified date | July 2019 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | Gynecologic Oncology Group, NCIC Clinical Trials Group |
United States, Canada,
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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