A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 900
- 主要终点
- 3 year of disease free survival
研究概览
简要总结
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
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
- •informed consensus of the enrolled patients
- •from 18 to 75 years old
- •proven to be primary adenocarcinoma of EGJ
- •pre-operative staging cT3-4N+M0
- •no prior other chemotherapy and/or radiation against the disease
- •normal function of all other vital organs including heart,liver ,kidney and so on
- •Eastern Cooperative Oncology Group performance status: 0~2
排除标准
- •history of other malignancy
- •allergic reaction to capecitabine or oxaliplatin
- •enrolled in other clinical trials
- •abnormal GI tract function
- •dysfunction of other organs
- •pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
- •other situations judged as not adaptive to the study by investigators
研究组 & 干预措施
Chemoradiation
weekly 5-Fu and oxaliplatin
干预措施: chemoradiation with weekly 5Fu and oxaliplatin (Radiation)
FLOT
Eight perioperative chemotherapy cycles
干预措施: Perioperative mFLOT (Drug)
FOLFOX
Twelve perioperative chemotherapy cycles
干预措施: Perioperative FOLFOX (Drug)
结局指标
主要结局
3 year of disease free survival
时间窗: 3 year
次要结局
- 5 year of overall survival(5 year)
- Rate of pathological complete remission(1 year)
- Anastomosis leak rate(1 year)
研究者
Jian Xiao
Deputy Director
Sixth Affiliated Hospital, Sun Yat-sen University