Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer
NCT ID: NCT00217633
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (pelvic exenteration)
Patients undergo pelvic exenteration within 14 days after study entry.
Conventional Surgery
Interventions
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Conventional Surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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D. McMeekin
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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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
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 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
M D Anderson Cancer Center
Houston, Texas, United States
Auburn Regional Medical Center
Auburn, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
Capital Medical Center
Olympia, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Northwest CCOP
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Multicare Health System
Tacoma, Washington, United States
M D Anderson International Spain
Madrid, Madrid, Spain
Countries
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Other Identifiers
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NCI-2009-00593
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000442396
Identifier Type: -
Identifier Source: secondary_id
GOG-0222
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0222
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0222
Identifier Type: -
Identifier Source: org_study_id
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