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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT02247232
Eligibility Criteria:
Inclusion Criteria:
1. FIGO stage (2008): IIIB, cervical cancer;
2. Pathologically confirmed squamous cell carcinoma of the cervix;
3. Patients with treatment-naive cervical cancer;
4. Patients without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at screening if CT data \[film or electronic image\] within 30 days before informed consent are available and can be provided for central imaging assessment);
5. Patients ≥21, ≤79 years of age at informed consent;
6. Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
7. Eastern Cooperative Oncology Group Performance Status: 0-2;
8. Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed); (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory; (6) Renal function:
1. If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
2. If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
9. Patients who are willing to give informed consents. "
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
79 Years
Study:
NCT02247232
Study Brief:
Protocol Section:
NCT02247232