Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
OBJECTIVES:
Primary
- Correlate progression-free survival and overall survival with tumor size, time interval
between primary cancer management and pelvic exenteration, and presence or absence of
pelvic sidewall fixation by clinical examination in patients with recurrent cervical
cancer treated with pelvic exenteration.
Secondary
- Determine quality of life of patients treated with this procedure.
- Correlate quality of life with reconstructive technique (e.g., no ostomy or ≥ 1 ostomy)
in patients treated with this procedure.
OUTLINE: Patients undergo pelvic exenteration within 14 days after study entry.
Quality of life is assessed at baseline and at 6, 12, and 24 months after surgery.
After completion of study treatment, patients are followed within 30 days, every 3 months
for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 275 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Correlation of progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pelvic sidewall fixation by clinical examination
No
D. Scott McMeekin, MD
Study Chair
Oklahoma University Cancer Institute
United States: Federal Government
CDR0000442396
NCT00217633
January 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Colorado Gynecologic Oncology Group, PC | Aurora, Colorado 80010 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |