A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.
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
- •Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
- •Any prior chemotherapy is allowed in this protocol
- •No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
- •No prior abdominal or pelvic radiotherapy
- •Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
- •Patients must have normal organ and marrow function as defined below:
- •Leukocytes greater than or equal to 3,000 G/L
- •Platelets: greater than or equal to 100,000/mm3
- •Hemoglobin:greater than or equal to 10g/L
- •Total bilirubin: within normal institutional limits
- •AST/ALT: less than or equal to 1.5 times the upper limit
- •Creatinine within normal upper limits
- •Informed consent
排除标准
- •Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
- •With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
- •History of allergic reactions attributed to similar chemical or biologic complex to S-1
- •Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- •History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- •History of prior radiation to the abdomen
- •Pregnant or lactating females
研究组 & 干预措施
S-1 based chemoradiotherapy
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
干预措施: intensity-modulated radiotherapy (Radiation)
S-1 based chemoradiotherapy
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
干预措施: S-1 (Drug)
结局指标
主要结局
Overall survival
时间窗: 3 years
Locoregional recurrence free survival
时间窗: 3 years
Distant metastasis free survival
时间窗: 3 years
Disease free survival
时间窗: 3 years
次要结局
- Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0(during treatment and within the first 30 days after completion of chemoradiotherapy)
研究者
Wang Xin
Cancer Hospital
Chinese Academy of Medical Sciences