Trial to Optimally Show the Pharmacological Action of Z-100

Inclusion criteria

• FIGO stage (2008): IIIB, cervical cancer
• Pathologically confirmed squamous cell carcinoma of the cervix
• Subjects with treatment-naive cervical cancer
• Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node
• Subjects ≥21, ≤79 years of age at informed consent
• Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy
• Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy
• Eastern Cooperative Oncology Group Performance Status: 0-2
• Subjects with the following organ functions; (1) WBC ≥3,000/mm3 (2) Platelet count ≥100,000/mm3 (3) Hemoglobin ≥9.5 g/dL (correction by medication, e.g. blood transfusion, iron compounds, 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) Creatinine clearance: ≥50 mL/min
• Subjects who are willing to give informed consent

Exclusion criteria

• Subjects who have a double cancer or are being treated for that
• Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent
• Subjects with cancer of the cervical stump which is judged by the investigator
• Subjects who have a history of being diagnosed of autoimmune disease
• Subjects who have a history of radiotherapy in the pelvis
• Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum
• Subjects complicated with a serious drug allergy
• Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)
• Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period
• Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)
• Subjects with symptomatic tuberculosis at the date of obtaining consent
• Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent
• Other subjects considered inappropriate to participate in the trial by the investigator