phase iii study of s-1 + cisplatin vs cisplatin in cervical cancer

Conditions: Cervical Cancer

Summary: this study is an open-label, multicenter, multinational, two-arm, parallel randomized phase 3 study evaluating the efficacy and safety of s-1+cisplatin versus single-agent cisplatin in patients with stage ivb, recurrent or persistent carcinoma of the cervix.

japanese phase ii study of s-1 in cervical cancer suggested promising response rate and good tolerability. since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent cisplatin or cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of s-1 in combination with cisplatin compared with single-agent cisplatin.

Eligibility criteria:
inclusion criteria: * patients with histologically proven cervical carcinoma (all histological subtype will be included). * patients who have stage ivb, recurrent or persistent disease. * patients who are not amenable to curative treatment with surgery and/or radiotherapy. * patients who have not received chemotherapy or chemoradiotherapy after diagnosis of recurrent, persistent, or stage ivb disease. * if the patient have received chemotherapy, radiotherapy or chemoradiotherapy as previous treatment, following interval must have elapsed from the last administration of treatment: 1. chemotherapy: 21 days 2. radiotherapy: 21 days\* 3. chemoradiotherapy: 42 days\* if there have been residual disease in previously irradiated field and without disease progression since the (chemo) radiotherapy, 90 days must have elapsed after the last administration of irradiation. * patients who have adequate hematologic, hepatic and renal functions as defined below: * hemoglobin: ≥ 8.0 g/dl * neutrophil count: ≥ 2,000/mm\^3 * platelet count: ≥ 100,000/mm\^3 * total serum bilirubin: ≤ 1.5 times the upper limits of normal (uln) * ast (got), alt (gpt): ≤ 2.5 times the uln. if abnormal values are associated with hepatic metastasis: ≤ 5.0 times the uln * serum creatinine: ≤ uln or creatinine clearance: ≥ 50 ml/min * patients who have an ecog performance status : 0-1. * age: ≥ 20 years old. * patients who can take pills orally. * patients who signed the written consent form. exclusion criteria: * patients who have known hypersensitivity to 5-fu or cisplatin. * patients who are receiving concomitant treatment with drugs interacting with s-1. * patients who are receiving concomitant treatment with drugs interacting with cisplatin. * patients who were administered other investigational products within 30 days before the initiation of study treatment. * patients who were previously treated with s-1. * patients who had received platinum-containing chemotherapy or chemoradiotherapy and whose disease progressed during the therapy. * patients who suffer from active infection (e.g. fever ≥ 38°c). * patients who have serious complications. * patients with bleeding which requires hemostasis treatment. * patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. * patients with uncontrolled pleural effusion and/or ascites requiring drainage at least twice a week. * patients with symptomatic brain metastasis or history of brain metastasis. * patients who have unmanageable bowel movement (ex. watery stool, chronic constipation). * patients with active double cancer. * patients who are pregnant or lactating. * patients who are considered to be inappropriate to the subject of this study by the investigator.