Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The ratio of patients occured Grade 3 or higher adverse events
研究概览
简要总结
The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed.;
- •Age: 18-70 years old, sex is not restricted;
- •Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation;
- •Received D0 or D1 operation, no tumor residual (R0);
- •Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;
- •Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;
- •Liver function: ALT or AST is less than or equal to 2.5 times of the normal high value (ULN); bilirubin is less than 1.5*ULN, serum APK is less than 2.5 * ULN;
- •Renal function: serum creatinine is less than 1.5 * ULN, and creatinine clearance rate is more than 60ml/min;
- •No previous chemotherapy or radiation therapy history;
- •No organ transplant history;
- •Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;
- •Men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before , during and after the course of the study
排除标准
- •Received D2 radical operation;
- •Tumor residual (R1/R2);
- •There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;
- •Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;
- •Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;
- •Anticipate other clinical trials in four weeks before enrollment.
- •Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.
- •Drug abuse history or alcohol addiction;
- •Active infection existed.
- •with severe malnutrition or severe anemia;
- •Human immunodeficiency virus (HIV) infection;
- •Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;
- •Can not tolerate this study or may be allergic to the drug used in this study;
- •Persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.
研究组 & 干预措施
postoperative CRT
postoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4).
干预措施: Raltitrexed (Drug)
postoperative CRT
postoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4).
干预措施: postoperative radiotherapy (Radiation)
结局指标
主要结局
The ratio of patients occured Grade 3 or higher adverse events
时间窗: From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT.
次要结局
- 2-year local-regionally recurrence rate(2 year)
- 3-year local-regionally recurrence rate(3 year)
- 2-year disease-free survival probability(2 year)
- 3-year disease-free survival probability(3 year)
- 2-year overall survival probability(2 year)
- 3-year overall survival probability(3 year)
研究者
Zhou Fuxiang
Principal Investigator, Clinical Professor
Zhongnan Hospital