Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- The patient's survival time and recurrence time
研究概览
简要总结
Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the gastroesophageal junction.
- •Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
- •Eastern Cooperative Oncology Group (ECOG) performance status≤
- •Informed consent obtained.
排除标准
- •Combined with other malignant tumors.
- •Eastern Cooperative Oncology Group (ECOG) performance status>
- •Combined with severe organ dysfunction.
- •Pregnancy
研究组 & 干预措施
CCRT group
The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
干预措施: Preoperative concurrent chemoradiotherapy (Radiation)
CCRT group
The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
干预措施: Radical D2 total gastrectomy (Procedure)
CCRT group
The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
干预措施: Adjuvant chemotherapy (Drug)
CT group
The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
干预措施: Radical D2 total gastrectomy (Procedure)
CT group
The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
干预措施: Adjuvant chemotherapy (Drug)
结局指标
主要结局
The patient's survival time and recurrence time
时间窗: Up to 3 years
3-year overall survival 1-year and 3-year recurrence free survival
次要结局
- The number of patients with complications(Within 30 days after the day of operation)
研究者
Jiafu Ji
President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory)
Peking University