Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer (NCT00217633) | Clinical Trial Compass
CompletedPhase 2
Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer
United States38 participantsStarted 2006-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clini…
What they're measuring
1
Overall survival
Timeframe: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
2
Progression-free survival
Timeframe: 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