A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- PCR rate
研究概览
简要总结
This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma
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
- •Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
- •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
- •Any prior chemotherapy or other cancer treatment prior to this protocol
- •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 or Xeloda or Oxaliplatin
- •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
Total Neoadjuvant Chemoradiotherapy
Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery
干预措施: SIB-IMRT (Radiation)
Total Neoadjuvant Chemoradiotherapy
Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery
干预措施: S-1 (Drug)
Total Neoadjuvant Chemoradiotherapy
Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery
干预措施: SOX (Drug)
Total Neoadjuvant Chemoradiotherapy
Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
PCR rate
时间窗: 6-8 months
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
次要结局
- Acute chemotherapy/Chemoradiotherapy toxicities(6-8 months)
- R0 resection rate(6-8 months)
- surgery complications(6-8 months)
- Tumor down-staging(6-8 months)
研究者
Jing Jin, M.D.
Chinese Academy of Medical Sciences and Peking Union Medical College
Chinese Academy of Medical Sciences