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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00046969
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IIB, III, or IVA cervical cancer
* No chorion carcinoma or neuroendocrine small cell carcinoma
* Previously untreated disease
* Must be scheduled to undergo radiotherapy and receive cisplatin as primary therapy
* Hemoglobin 8.0-13.0 g/dL
* No relevant acute bleeding within the past 3 months, including anemia caused by gross bleeding from tumor
* No distant metastasis
* No positive para-aortic lymph nodes
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* WHO 0-2
Life expectancy
* At least 3 months
Hematopoietic
* See Disease Characteristics
* WBC greater than 3,000/mm3
* Platelet count greater than 100,000/mm3
* No hemolytic anemia
* No transferrin saturation less than 20% that cannot be treated with IV iron
* No hemoglobinopathies (i.e., sickle cell disease or thalassemia of all types)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Transaminases no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal
* Creatinine clearance greater than 60 mL/min
Cardiovascular
* No chronic heart failure
* No New York Heart Association class II-IV heart disease
* No uncontrolled arterial hypertension (systolic blood pressure at least 170 mmHg, diastolic blood pressure at least 100 mmHg)
* No prior deep vein thrombosis
* No thrombocytosis
Other
* No vitamin B12 deficiency
* No folic acid deficiency
* No newly diagnosed (unstable) epilepsy
* No acute infection
* No other malignancy within the past 5 years except basal cell carcinoma in situ
* No known peripheral neuropathy or moto-sensory neurotoxicity grade 2 or greater
* No impaired hearing grade 2 or greater
* No hypersensitivity to benzyl alcohol, benzoic acid, benzalkonium chloride, or any excipients of cisplatin preparations
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 months since prior epoetins or related compounds
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy for cervical cancer
Surgery
* Not specified
Other
* At least 30 days since prior investigational drugs
* No prior systemic antineoplastic therapy for cervical cancer
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00046969
Study Brief:
Protocol Section:
NCT00046969