Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 86
- 主要终点
- In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet.
研究概览
简要总结
The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.
详细描述
Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.
Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma
- •Subjects must be able to take orally
- •Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11
- •Within 4 weeks from the diagnosis of PD
- •Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination
- •ECOG performance status ≤ 1
- •Follow up Age 20 or over
- •Life expectancy estimated more than 12 weeks
- •Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3
- •Creatinine ≤ upper normal limit (UNL)
- •Total bilirubin ≤ 1.5 X UNL
- •Written informed consent
排除标准
- •S-1 + CPT-11 was employed as a first-line
- •Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy
- •After S-1 adjuvant
- •Suspended cases by adverse events by S-1 or S-1 combination
- •Excessive amounts of ascites require drainage
- •Known brain metastases
- •History of hypersensitivity to fluoropyrimidines and CPT-11
- •Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- •Active double cancer
- •Gastrointestinal bleeding
- •Any subject judged by the investigator to be unfit for any reason to participate in the study
研究组 & 干预措施
A
CPT-11+ S-1
干预措施: S-1 + irinotecan (Drug)
B
CPT-11
干预措施: irinotecan (Drug)
结局指标
主要结局
In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet.
时间窗: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization
次要结局
- Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line(2 years)