A Prospective, Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Concomitant Boost Intensity-Modulated Radiotherapy With S-1 in Locally Advanced Gastric Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 cT3-4N0M0 or anyTN+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
Neoadjuvant Chemoradiotherapy (NCRT)
NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm.
干预措施: SIB-IMRT (Radiation)
Neoadjuvant Chemoradiotherapy (NCRT)
NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm.
干预措施: S-1 (Drug)
Neoadjuvant Chemoradiotherapy (NCRT)
NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm.
干预措施: Surgery (Procedure)
Neoadjuvant Chemoradiotherapy (NCRT)
NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm.
干预措施: SOX (Drug)
Neoadjuvant Chemotherapy (NCT)
NCT arm consists of neoadjuvant three cycles of SOX(S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX.
干预措施: Surgery (Procedure)
Neoadjuvant Chemotherapy (NCT)
NCT arm consists of neoadjuvant three cycles of SOX(S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX.
干预措施: SOX (Drug)
结局指标
主要结局
R0 resection rate
时间窗: 2-3 months
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after neoadjuvant therapy.
次要结局
- Postoperative complications(2-3 months)
- Pathological response rate(2-3 months)
- Tumor down-staging(2-3 months)
- Acute chemotherapy/Chemoradiotherapy toxicities(6-8 months)
- Locoregional recurrence free survival(3 years)
- Overall survival(3 years)
- Distant metastasis free survival(3 years)
研究者
Jing Jin, M.D.
MD
Chinese Academy of Medical Sciences