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Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.
PRIMARY OBJECTIVE: I. 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 OBJECTIVES: I. Determine quality of life of patients treated with this procedure. II. 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Georgia Regents University Medical Center
Augusta, Georgia, United States
Memorial University Medical Center
Savannah, Georgia, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Union Hospital of Cecil County
Elkton MD, Maryland, United States
Start Date
January 1, 2006
Primary Completion Date
January 1, 2013
Last Updated
May 29, 2015
38
ACTUAL participants
Conventional Surgery
PROCEDURE
Lead Sponsor
Gynecologic Oncology Group
Collaborators
NCT05639972
NCT06654011
Data Source & Attribution
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