Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer
- Conditions
- Cervical Adenosquamous CarcinomaRecurrent Cervical CarcinomaCervical AdenocarcinomaCervical Small Cell CarcinomaCervical Squamous Cell Carcinoma
- Interventions
- Procedure: Conventional Surgery
- Registration Number
- NCT00217633
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
-
Diagnosis of cervical cancer
- Any histology
- Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis
-
Meets 1 of the following stage criteria:
- Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month
- Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy
-
Must have received prior primary treatment, including any of the following:
- Surgery with or without post operative radiotherapy with or without chemotherapy
- Primary radiotherapy with or without chemotherapy
- Neoadjuvant chemotherapy followed by surgery
- Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy
-
Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry
-
Deemed to be a good surgical candidate
- No evidence of distant disease or disease that is felt to be unresectable by physical examination
- Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon
-
Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible
-
Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible
-
-
No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography
-
No noncervical primary tumor
-
No prior anterior or posterior pelvic exenteration
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (pelvic exenteration) Conventional Surgery Patients undergo pelvic exenteration within 14 days after study entry.
- Primary Outcome Measures
Name Time Method Overall survival From entry to protocol to death; or for living patients, the date of last contact, up to 93 years Progression-free survival 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
- Secondary Outcome Measures
Name Time Method Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX) At baseline, 6, 12, and 24 months post exenteration
Trial Locations
- Locations (39)
Cleveland Clinic Cancer Center/Fairview Hospital
🇺🇸Cleveland, Ohio, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Georgia Regents University Medical Center
🇺🇸Augusta, 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
Memorial University Medical Center
🇺🇸Savannah, Georgia, United States
University of Minnesota Medical Center-Fairview
🇺🇸Minneapolis, Minnesota, United States
The Cancer Institute of New Jersey Hamilton
🇺🇸Hamilton, New Jersey, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Hillcrest Hospital Cancer Center
🇺🇸Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Associates-Midtown
🇺🇸Tulsa, Oklahoma, United States
Tulsa Cancer Institute
🇺🇸Tulsa, Oklahoma, United States
Gynecologic Oncology Group
🇺🇸Philadelphia, Pennsylvania, United States
Auburn Regional Medical Center
🇺🇸Auburn, Washington, United States
Colorado Gynecologic Oncology Group
🇺🇸Aurora, Colorado, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Northwest CCOP
🇺🇸Tacoma, Washington, United States
MultiCare Good Samaritan Hospital
🇺🇸Puyallup, Washington, United States
Saint Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Saint Francis Hospital
🇺🇸Federal Way, Washington, United States
Providence Regional Cancer System-Centralia
🇺🇸Centralia, Washington, United States
M D Anderson International Spain
🇪🇸Madrid, Spain
Saint Clare Hospital
🇺🇸Lakewood, Washington, United States
MultiCare Allenmore Hospital
🇺🇸Tacoma, Washington, United States
MultiCare Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Multicare Health System
🇺🇸Tacoma, Washington, United States
Capital Medical Center
🇺🇸Olympia, Washington, United States
Providence - Saint Peter Hospital
🇺🇸Olympia, Washington, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States