Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer
Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
4 other identifiers
interventional
38
2 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedMay 29, 2015
May 1, 2015
7 years
September 20, 2005
May 27, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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
Study Arms (1)
Treatment (pelvic exenteration)
EXPERIMENTALPatients undergo pelvic exenteration within 14 days after study entry.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (39)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Georgia Regents University Medical Center
Augusta, Georgia, 30912, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Union Hospital of Cecil County
Elkton MD, Maryland, 21921, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146, United States
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Auburn Regional Medical Center
Auburn, Washington, 98001, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166, United States
Capital Medical Center
Olympia, Washington, 98507, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
MultiCare Allenmore Hospital
Tacoma, Washington, 98405, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
Northwest CCOP
Tacoma, Washington, 98405, United States
Saint Joseph Medical Center
Tacoma, Washington, 98405, United States
Multicare Health System
Tacoma, Washington, 98415, United States
M D Anderson International Spain
Madrid, Madrid, 28033, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
D. McMeekin
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
January 1, 2006
Primary Completion
January 1, 2013
Last Updated
May 29, 2015
Record last verified: 2015-05