Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose AND Dose limited toxicity
研究概览
简要总结
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
详细描述
After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical stage T3-4N+M0
- •Gastric cancer or Siewert II/III esophagogastric junction carcinoma;
- •Pathologically confirmed adenocarcinoma;
- •18-75 years old, male or female;
- •Karnofsky score >= 70;
- •White blood cell count >= 4 x 109 / L; platelet count >= 100 x109/L; serum creatinine =< 1 x upper limit of normal, total bilirubin =< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =< 2.5 x upper limit of normal, alkaline phosphatase =< 5 x upper limit of normal.
排除标准
- •Any chemotherapy or radiotherapy history before enrollment
- •Siewert I EGJ cancer
研究组 & 干预措施
Hypo-fractionated radiotherapy
Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer
干预措施: Hypo-fractionated radiotherapy (Radiation)
Hypo-fractionated radiotherapy
Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer
干预措施: S1 (Drug)
结局指标
主要结局
Maximum tolerated dose AND Dose limited toxicity
时间窗: From date of enrollment until one month after chemo-radiotherapy
To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy
次要结局
- Response rate(From date of enrollment until surgery, assessed up to 2 months)
- 2-year disease-free survival(From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months)
研究者
LI Ning
Principal Investigator
Chinese Academy of Medical Sciences