Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified
About this trial
This is an interventional treatment trial for Cervical Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:
- Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
- White blood cells (WBC) >= 3.0 x 10^9/L
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelet count >= 100 x 10^9/L
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN (if both tests are done, both results need to be =< 2.5 x ULN)
- Creatinine =< ULN (Common Toxicity Criteria [CTC] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
- Written informed consent
Exclusion Criteria:
- Any previous pelvic radiotherapy
- Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT])
- FIGO 2008 stage IIIA disease
- Patients assessed at presentation as requiring interstitial brachytherapy treatment
- Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
- Previous chemotherapy for this tumor
- Evidence of distant metastases
- Prior diagnosis of Crohn's disease or ulcerative colitis
- Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4)
- Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
- Patients who are pregnant or lactating
- Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
- Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who are known to be human immunodeficiency virus (HIV) positive
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Alaska Women's Cancer Care
- Providence Alaska Medical Center
- Cancer Center at Saint Joseph's
- Gynecologic Oncology Group of Arizona
- Saint Joseph's Hospital and Medical Center
- Arizona Oncology Associates-Biltmore Cancer Center
- Arizona Oncology Associates-West Orange Grove
- Arizona Oncology Associates-Wilmot
- University of Arkansas for Medical Sciences
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- John Muir Medical Center-Concord Campus
- Sutter Davis Hospital
- Kaiser Permanente-Fremont
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Mercy Cancer Center - Sacramento
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Palo Alto Medical Foundation-Sunnyvale
- Olive View-University of California Los Angeles Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- John Muir Medical Center-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- University of Connecticut
- Hartford Hospital
- The Hospital of Central Connecticut
- Yale University
- Christiana Care Health System-Christiana Hospital
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- University of Florida Health Science Center - Gainesville
- Jackson Memorial Hospital-Holtz Children's Hospital
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Orlando Health Cancer Institute
- Sarasota Memorial Hospital
- Grady Health System
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Northside Hospital
- Northeast Georgia Medical Center-Gainesville
- Central Georgia Gynecologic Oncology
- The Cancer Center of Hawaii-Pali Momi
- Queen's Medical Center
- University of Hawaii Cancer Center
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Kootenai Health - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Loyola University Medical Center
- Illinois CancerCare-Ottawa Clinic
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Northwestern Medicine Cancer Center Warrenville
- Michiana Hematology Oncology PC-Elkhart
- Indiana University/Melvin and Bren Simon Cancer Center
- Saint Vincent Hospital and Health Care Center
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- University of Kansas Cancer Center
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- Norton Hospital Pavilion and Medical Campus
- Norton Brownsboro Hospital and Medical Campus
- Woman's Hospital
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Maine Medical Center-Bramhall Campus
- Maine Medical Center- Scarborough Campus
- University of Maryland/Greenebaum Cancer Center
- Walter Reed National Military Medical Center
- Baystate Medical Center
- UMass Memorial Medical Center - Memorial Division
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- West Michigan Cancer Center
- Sparrow Hospital
- William Beaumont Hospital-Royal Oak
- Munson Medical Center
- Mercy Hospital
- Fairview Southdale Hospital
- Abbott-Northwestern Hospital
- University of Minnesota/Masonic Cancer Center
- United Hospital
- Minnesota Oncology Hematology PA-Woodbury
- University of Mississippi Medical Center
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Nebraska Methodist Hospital
- University of Nebraska Medical Center
- Women's Cancer Center of Nevada
- Wentworth-Douglass Hospital
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Hackensack University Medical Center
- Morristown Medical Center
- Virtua Memorial
- Jersey Shore Medical Center
- Rutgers Cancer Institute of New Jersey
- MD Anderson Cancer Center at Cooper-Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Lovelace Radiation Oncology
- Memorial Medical Center - Las Cruces
- Women's Cancer Care Associates LLC
- Montefiore Medical Center-Einstein Campus
- State University of New York Downstate Medical Center
- New York-Presbyterian/Brooklyn Methodist Hospital
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- New York Hospital Medical Center of Queens
- Memorial Sloan Kettering Westchester
- Queens Hospital Center
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- NYU Winthrop Hospital
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Lenox Hill Hospital
- Memorial Sloan Kettering Cancer Center
- Highland Hospital
- University of Rochester
- Memorial Sloan Kettering Sleepy Hollow
- Stony Brook University Medical Center
- Memorial Sloan Kettering Nassau
- Cone Health Cancer Center at Alamance Regional
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Atrium Health Cabarrus/LCI-Concord
- New Hanover Regional Medical Center/Zimmer Cancer Center
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Summa Health System - Akron Campus
- University of Cincinnati/Barrett Cancer Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Miami Valley Hospital
- Kettering Medical Center
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- University of Toledo
- Wright-Patterson Medical Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Providence Portland Medical Center
- Abington Memorial Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Drexel University School of Medicine
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- UPMC-Magee Womens Hospital
- West Penn Hospital
- UPMC-Shadyside Hospital
- Reading Hospital
- Women and Infants Hospital
- AnMed Health Cancer Center
- Medical University of South Carolina
- Gibbs Cancer Center-Gaffney
- Saint Francis Hospital
- Gibbs Cancer Center-Pelham
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- Black Hills Obstetrics and Gynecology
- Rapid City Regional Hospital
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology Bedford
- Texas Oncology at Baylor Charles A Sammons Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- Texas Oncology - Fort Worth Cancer Center
- University of Texas Medical Branch
- Lyndon Baines Johnson General Hospital
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Memorial Hermann Texas Medical Center
- West Texas Cancer Center
- Houston Methodist Sugar Land Hospital
- Intermountain Medical Center
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- University of Virginia Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- MultiCare Auburn Medical Center
- MultiCare Gig Harbor Medical Park
- MultiCare Good Samaritan Hospital
- MultiCare Tacoma General Hospital
- Aurora BayCare Medical Center
- University of Wisconsin Hospital and Clinics
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora West Allis Medical Center
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
- Juravinski Cancer Centre at Hamilton Health Sciences
- London Regional Cancer Program
- University Health Network-Princess Margaret Hospital
- CHUM - Hopital Notre-Dame
- McGill University Department of Oncology
- CHUM - Centre Hospitalier de l'Universite de Montreal
- The Research Institute of the McGill University Health Centre (MUHC)
- Allan Blair Cancer Centre
- Zhongshan Hospital Fudan University
- King Faisal Specialist Hospital and Research Centre
- National University Hospital Singapore
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (cisplatin, radiation therapy, brachytherapy)
Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.