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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT02365935
Eligibility Criteria:
Inclusion Criteria:
* patients with squamous cell, adenosquamous or adenocarcinoma of the cervix
* Stage IB2-IIB according to the Inyernational Federation of Gynecology and Obstetrics (FIGO)
* age between 18 and 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* normal cardiac and respiratory functions
* absence of secondary malignancies
* no previous surgical, chemotherapic and/or radiotherapic treatment for secondary malignancies
* informed consent obtained from the patient.
Exclusion Criteria:
* histological confirmation of papillary serous, mucinous, clear cell, squamous cell, mixed and undifferentiated carcinoma of the uterus
* abnormal hepatic function (transaminases \> 2.5 x upper limit, serum bilirubin \> 1,5 x upper limit)
* abnormal renal function (creatinine clearance \<60 mL/min and/or serum creatinine\>2.0 mg/100 mL) function
* abnormal bone marrow function (absolute neutrophil count \<1,5 x 109/L or platelet count \< 100 x 109/L or hemoglobin \< 9 g/dL
* severe or uncontrolled infection, other systemic diseases or mental illness; and
* pregnant women. Clinical staging was performed according to the NCCN criteria, and included pelvic examination, cervical biopsy, abdomen-pelvis Computed Tomography, chest X-ray; examination under anesthesia, cystoscopy and/or proctoscopy if clinically indicated (National Comprehensive Cancer Network, Clinical Practicw Guidelines in Oncology. Cervical Cancer, Version 2.2015)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02365935
Study Brief:
Protocol Section:
NCT02365935