Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
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This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.
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Layout table for eligibility information
Ages Eligible for Study:
21 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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. "