Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Completed · Phase 2

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT00217633

Run by

Gynecologic Oncology Group

People needed

38

Starts

2006-01-01

Last updated by the study team

2015-05-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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