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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00590967
Eligibility Criteria:
Inclusion Criteria:
* Patients must have carcinoma of the uterine cervix.
* Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.
* International Federation of Gynecology and Obstetrics (FIGO) Stage I to IVA
* Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes), by PET.
* Patients must have a Karnofsky Performance Status of \>= 60 and no medical contraindications to the administration of chemotherapy.
* Age \>= 18.
* Adequate bone marrow function: white blood cells (WBC) \>= 4000/mm3, platelets \>= 100,000 mm3.
* Adequate renal function: BUN \<= 25 mg/dl, creatinine \<= 1.2 mg/dl (urinary diversion is permitted to improve renal function).
* Patients must have bilirubin \<= 1.5 mg/dl.
* Signed study-specific informed consent.
Exclusion Criteria:
* No positive lymph nodes by FDG PET
* Positive supraclavicular lymph nodes by FDG PET Scan or evidence of more distant disease.
* FIGO Stage IVB+ Cervical Cancer
* No prior (within 5 years) or simultaneous malignancies (other than cutaneous basal cell carcinoma).
* Karnofsky Performance Status \<60.
* Patients with significant medical illness preventing the use of full dose chemotherapy are excluded.
* Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
* Life expectancy \< 6 months.
* Patients with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL) are not eligible.
* No prior surgery for treatment of disease other than exploratory laparotomy or biopsy.
* No previous systemic chemotherapy.
* No pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding.
* Pregnant women are ineligible and those of child-bearing potential should practice contraception.
* Patients with abnormal liver function tests
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00590967
Study Brief:
Protocol Section:
NCT00590967