A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
详细描述
Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically proven gastric adenocarcinoma which is complete resected
- •ECOG performance status of 1 or lower
- •Adequate bone marrow function
- •absolute neutrophil count [ANC] ≥1,500µL, and platelets ≥100,000/µL
- •Adequate kidney function (serum creatinine < 1.5 mg/dL)
- •Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL) serum transaminases levels <2 times UNL
- •No prior chemotherapy
排除标准
- •Other tumor type than adenocarcinoma
- •Evidence of distant metastasis
- •Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- •Uncontrolled infection
- •Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry
- •History of significant neurologic or psychiatric disorders including dementia or seizures
- •Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- •Symptoms of gastrointestinal obstruction
- •concomitant drug medication: The following drugs cause drug interaction with S-1.
研究组 & 干预措施
S-1,chemoradiotherapy, adjuvant treatment
Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given.
干预措施: S-1 (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3 years
次要结局
- Overall Survival(3 years)
- Number of participants with adverse events as a measure of safety and tolerability(3 year)
研究者
Sang-Hee Cho
Professor
Chonnam National University Hospital