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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT00098995
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
* Stage IB, IIA, IIB, III, or IVA disease
* No evidence of involvement of para-aortic nodes by CT scan, MRI, fluorodeoxyglucose positron emission tomography, or lymphadenectomy
* Involvement of common iliac nodes allowed
* No evidence of distant metastases
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* ECOG 0-2
Life expectancy
* More than 6 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin \< 1.25 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
Renal
* Calculated creatinine clearance ≥ 60 mL/min OR
* Glomerular filtration rate ≥ 60 mL/min
Cardiovascular
* No significant cardiac disease that would preclude IV fluid load required for administration of cisplatin
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* No symptomatic peripheral neuropathy ≥ grade 2
* No clinically significant sensori-neural hearing impairment interfering with activities of daily living or requiring a hearing aid
* Audiometric changes alone of any severity allowed
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to tirapazamine or cisplatin
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent epoetin alfa
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
* No concurrent pegfilgrastim
Chemotherapy
* No prior chemotherapy for another malignancy
Endocrine therapy
* Not specified
Radiotherapy
* No prior pelvic or abdominal radiotherapy for another malignancy
* No prior radiotherapy to ≥ 15% of bone marrow-bearing areas
* No concurrent intensity-modulated radiotherapy
* No concurrent interstitial brachytherapy
Surgery
* Not specified
Other
* No prior treatment for invasive cervical cancer
* No other concurrent therapeutic investigational agents
* No other concurrent anticancer therapy
* No concurrent systemic retinoids
* No concurrent amifostine
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00098995
Study Brief:
Protocol Section:
NCT00098995