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:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00017004
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Stage IIB, IIIB, or IVA
* Primary, previously untreated disease
* Hemoglobin less than 14 g/dL at presentation
* Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy
* Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy
* No involvement of the lower third of vagina
* No carcinoma of the cervical stump
* Performance status - GOG 0-3
* See Disease Characteristics
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal
* Creatinine no greater than 2.0 mg/dL
* No uncontrolled hypertension
* No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)
* No active hemolysis
* No history of pulmonary embolism
* No septicemia or severe infection
* No circumstances that would preclude study participation
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No history of hypersensitivity to epoetin alfa or human albumin
* No diagnosis of vitamin B\_12 or folic acid deficiency
* No recent (within the past 3 months) or uncontrolled seizure disorder
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* See Disease Characteristics
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00017004
Study Brief:
Protocol Section:
NCT00017004