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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Overall survival
Time frame: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
Progression-free survival
Time frame: From study entry to date of reappearance or increasing parameters of disease or death, or to date of last contact for patients without disease progression, up to 93 years
Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)
Time frame: At baseline, 6, 12, and 24 months post exenteration
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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
...and 29 more locations