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

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.