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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00054067
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:
* Squamous cell carcinoma
* Adenocarcinoma
* Adenosquamous carcinoma
* Primary, previously untreated disease
* Exophytic cervical lesions greater than 4 cm in diameter OR
* Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer
* No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)
* No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)
* Eligible for radical hysterectomy and lymph node dissection
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal
Renal
* Creatinine no greater than 2.0 mg/dL
* No renal abnormalities requiring modification of radiation fields
Gastrointestinal
* No gastrointestinal bleeding
* No intestinal obstruction
Other
* Not pregnant
* Negative pregnancy test
* No septicemia or severe infection
* No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
* No circumstances that would preclude study completion or required follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* See Disease Characteristics
* No prior hysterectomy (total or subtotal)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00054067
Study Brief:
Protocol Section:
NCT00054067