Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT00217633
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00217633
Study Brief:
Protocol Section:
NCT00217633