AzTrials
AzTrials

Cervical AdenocarcinomaPhase 3NCT00262821

Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

A Phase 3 study testing cisplatin and tirapazamine in people with Cervical Adenocarcinoma and Cervical Adenosquamous Cell Carcinoma, run by National Cancer Institute (NCI) at 282 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
cisplatin and tirapazamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
282 sitesin 2 countries
Study dates
Feb 2006to Aug 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

282 sites in 2 countries.

282 sites in 2 countries

United States273 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Island Gynecologic Oncology

    Brightwaters, New York, 11718

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Fletcher Allen Health Care-Medical Center

    Burlington, Vermont, 05401

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Chattanooga Gynecological Oncology

    Chattanooga, Tennessee, 37403

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Memorial Hospital Colorado Springs

    Colorado Springs, Colorado, 80909

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Highlands Oncology Group PA - Fayetteville

    Fayetteville, Arkansas, 72703

  • Washington Regional Medical Center - Fayetteville

    Fayetteville, Arkansas, 72703

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33905

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555-0565

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Spectrum Health-Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Gynecologic Oncology of West Michigan PLLC

    Grand Rapids, Michigan, 49546

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Hawaii Minority Based CCOP

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Gynecologic Oncology of Indiana

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Queens Hospital Center

    Jamaica, New York, 11432

  • East Tennessee State University

    Johnson City, Tennessee, 37614-0054

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri, 64114

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri, 64154

  • Good Samaritan Hospital

    Kearney, Nebraska, 68847

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore-LIJ Health System CCOP

    Manhasset, New York, 11030

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

  • Mountainside Hospital

    Montclair, New Jersey, 07042

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Mercy Health Partners-Hackley Campus

    Muskegon, Michigan, 49442

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Meharry Medical College

    Nashville, Tennessee, 37208-3599

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06520

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • North Shore-LIJ Health System/Center for Advanced Medicine

    New Hyde Park, New York, 11040

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • New York University Langone Medical Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • UMDNJ - New Jersey Medical School

    Newark, New Jersey, 07103

  • Bon Secours Mary Immaculate Hospital

    Newport News, Virginia, 23602

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Bay Area Tumor Institute CCOP

    Oakland, California, 94609

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California Medical Center At Irvine-Orange Campus

    Orange, California, 92868

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas, 66210

  • Advocate Lutheran General Hospital.

    Park Ridge, Illinois, 60068

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • Western Regional CCOP

    Phoenix, Arizona, 85006

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604-3337

  • Good Samaritan Community Hospital

    Puyallup, Washington, 98372

  • Black Hills Obstetrics and Gynecology

    Rapid City, South Dakota, 57701

  • Center of Hope at Renown Medical Center

    Reno, Nevada, 89502

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Salem Hospital

    Salem, Oregon, 97301

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • Hematology and Oncology Associates of North East Pennsylvania

    Scranton, Pennsylvania, 18508

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71130

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Providence Hospital

    Southfield, Michigan, 48075

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Olive View-University of California Los Angeles Medical Center

    Sylmar, California, 91342

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Northwest CCOP

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • Multicare Health System

    Tacoma, Washington, 98415

  • Montefiore Medical Center-Weiler Division

    The Bronx, New York, 10461

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043

  • Maui Memorial Medical Center

    Wailuku, Hawaii, 96793

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Wilson Medical Center

    Wilson, North Carolina, 27893

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Wright-Patterson Medical Center

    Wright-Patterson Air Force Base, Ohio, 45433-5529

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

Canada9 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • CHUQ - Pavilion Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BCCA-Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

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

TERTIARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
cisplatin, tirapazamine
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • tirapazamineDrug

    Also called SR 4233, Tirazone, WIN 59075

    Given IV

Study groups in NCT00262821
Study groupRoleWhat they receive
Arm I (cisplatin)Active comparatorPatients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
Receives: Drug: cisplatin
Arm II (cisplatin, tirapazamine)ExperimentalPatients 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.
Receives: Drug: cisplatin; Drug: tirapazamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From study entry until first disease progression, death or date of last contact, up to 6 years

Secondary outcomes (2)

  1. Overall Survival

    The observed length of life from entry into the study to death or date of last contact.

    Measured: From study entry to death or last contact, up to 6 years

  2. 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.

    Measured: All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2005 (estimated)
  2. Study startFeb 2006
  3. Primary completionAug 2010
  4. Study completionAug 2010

Why it stopped: Study drug no longer available resulting in lack of study drug for participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262821
Sponsor's protocol ID
NCI-2009-00591
Other IDs
NCI-2009-00591, CAN-NCIC-GOG-0219, CDR0000455555, GOG-0219, GOG-0219, U10CA027469
Status last verified
Jul 2019
First submitted
6 Dec 2005
Last updated
23 Jul 2019

Publications

  • DiSilvestro PA, Ali S, Craighead PS, Lucci JA, Lee YC, Cohn DE, Spirtos NM, Tewari KS, Muller C, Gajewski WH, Steinhoff MM, Monk BJ. Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study. J Clin Oncol. 2014 Feb 10;32(5):458-64. doi: 10.1200/JCO.2013.51.4265. Epub 2014 Jan 6.

    PubMed 24395863

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin and tirapazamine in people with Cervical Adenocarcinoma and Cervical Adenosquamous Cell Carcinoma, run by National Cancer Institute (NCI) at 282 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 282 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival - Percentage of Patients Alive and Progression Free (time frame: From study entry until first disease progression, death or date of last contact, up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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