NCT00770874已完成3 期
Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 4
- 主要终点
- Overall Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Chemotherapy: 21 days
- •Radiotherapy: 21 days*
- •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-
- •Age: ≥ 20 years old.
- •Patients who can take pills orally.
- •Patients who signed the written consent form.
排除标准
- •Patients who have known hypersensitivity to 5-FU or Cisplatin.
- •Patients who are receiving concomitant treatment with drugs interacting with S-
- •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-
- •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.
研究组 & 干预措施
1
Experimental
S-1 + Cisplatin (arm A)
干预措施: S-1 + Cisplatin (arm A) (Drug)
2
Active Comparator
Cisplatin (arm B)
干预措施: Cisplatin (arm B) (Drug)
结局指标
主要结局
Overall Survival
时间窗: From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months
次要结局
- Progression Free Survival, Safety(About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment)
研究者
研究点 (4)
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