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 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT00452920
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell carcinoma of the uterine cervix
* Locally advanced (stage IIB- IVA) disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* WBC ≥ 3,000/mm\^3
* Creatinine normal
* Bilirubin normal
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) ≤ ULN OR AP ≤ 4 times ULN if SGOT and SGPT ≤ ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
* No history of severe allergic reactions to agents containing polysorbate 80
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would preclude compliance with study requirements
* No peripheral neuropathy ≥ grade 2
* No HIV positivity
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior unrelated therapy and recovered
* No prior chemotherapy or pelvic radiotherapy
* No other concurrent investigational agents or anticancer agents or therapies
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00452920
Study Brief:
Protocol Section:
NCT00452920