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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT00184093
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter.
* Cervical lesion which is measurable by physical examination.
* No prior therapy for invasive cervical cancer.
* GOG performance status 0-2
* Signed informed consent
* Patients must have adequate:
* Bone marrow function: absolute granulocyte count \> or = to 1500, platelet count \> 100,000.
* Renal function: creatinine \< or = to 1.8 mg/dl
* Hepatic function: bilirubin \< or = to 1.5 x normal, SGOT and alkaline phosphatase \< or = to 3 x normal
Exclusion Criteria:
* Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years.
* Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control.
* Patients with uncontrolled infection.
* Patients who are HIV positive
* Patients with psychiatric or social conditions that would interfere with consent or follow-up.
* Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00184093
Study Brief:
Protocol Section:
NCT00184093