Neoadjuvant Chemotherapy vs Neoadjuvant Chemoradiotherapy for Resectable Carcinoma Gastroesophageal junction : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of median survival rates in patient treated with NACT followed by surgery with NACTRT followed by surgery
研究概览
简要总结
The study is a prospective , double arm, single centric, randomized control trial to compare Neoadjuvant Chemotherapy followede by surgery vs Neoadjuvant Chemoradiotherapy followed by surgery for Resectable Carcinoma Gastroesophageal junction (seiwert type 1,2 and 3) in 50 consecutive patients who did not have distant metastasis on staging laparoscopy and had resectable disease locally. Our hypothesis is that there is no benefit in overall survival and complication rate between two groups. Our primary outcome would be to Compare of median survival rates in two groups , and secondary outcome will be to measure Pathological response; Progression free survival; number of R0 resections; treatment toxicity; quality of life of patients in two groups. Patients will be randomized to either arms after completion of workup and diagnostic laparoscopy by computer generated method if no distant metastasis found. At present either chemotherapy or chemoradiotherapy , both are recommended by NCCN for neoadjuvant therapy for gastroesophageal junction adenocarcinomas before surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients with resectable and hitologically proven adenocarcinoma of Gastroesophageal junction(type I,II,III) who are fit for surgery(ECOG performance status 0,1,2); No Distant metastasis on PET scan and Staging Laparoscopy.
排除标准
- •Distant metastasis on Staging Laparoscopy or on PET scan; refusal for informed consent for procedure; locally unresectable tumors; tumors falling in stage cT1N0 on Endoscopic ultrasound examination.
结局指标
主要结局
Comparison of median survival rates in patient treated with NACT followed by surgery with NACTRT followed by surgery
时间窗: 30 days from surgery ; 3 month; 6 month; 1 year; 3 years ; 5 years
次要结局
- Pathological response; Progression free survival; number of R0 resections; treatment toxicity; quality of life(30 days from surgery ; 3 month; 6 month; 1 year; 3 years ; 5 years)
