Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer

Inclusion criteria

• FIGO stage (2008): IIIB, cervical cancer;
• Pathologically confirmed squamous cell carcinoma of the cervix;
• Patients with treatment-naive cervical cancer;
• 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);
• Patients ≥21, ≤79 years of age at informed consent;
• Patients for whom it is considered possible to carry out intracavitary radiation in radiotherapy;
• Eastern Cooperative Oncology Group Performance Status: 0-2;
• 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:

• If combination therapy with cisplatin is planned, creatinine clearance: ≥50 mL/min;
• If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the upper limit of reference value at the clinical testing laboratory;
• Patients who are willing to give informed consents. "