Cervical Adenocarcinoma Clinical Trial
Official title:
Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
Verified date | May 2015 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | M D Anderson International Spain | Madrid | |
United States | Auburn Regional Medical Center | Auburn | Washington |
United States | Georgia Regents University Medical Center | Augusta | Georgia |
United States | Colorado Gynecologic Oncology Group | Aurora | Colorado |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Providence Regional Cancer System-Centralia | Centralia | Washington |
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 | Union Hospital of Cecil County | Elkton MD | Maryland |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey |
United States | Hartford Hospital | Hartford | Connecticut |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio |
United States | Lake University Ireland Cancer Center | Mentor | Ohio |
United States | University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Capital Medical Center | Olympia | Washington |
United States | Providence - Saint Peter Hospital | Olympia | Washington |
United States | Gynecologic Oncology Group | Philadelphia | Pennsylvania |
United States | MultiCare Good Samaritan Hospital | Puyallup | Washington |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Memorial University Medical Center | Savannah | Georgia |
United States | MultiCare Allenmore Hospital | Tacoma | Washington |
United States | Multicare Health System | 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 | Cancer Care Associates-Midtown | Tulsa | Oklahoma |
United States | Tulsa Cancer Institute | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | From entry to protocol to death; or for living patients, the date of last contact, up to 93 years | No | |
Primary | 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 | No | |
Secondary | 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 | No |
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