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临床试验/CTRI/2018/05/013757
CTRI/2018/05/013757招募中不适用

Neoadjuvant Chemotherapy vs Neoadjuvant Chemoradiotherapy for Resectable Carcinoma Gastroesophageal junction : a Randomized Controlled Trial

Dr Shivendra Singh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年4月27日最近更新:

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)

研究者

发起方
Dr Shivendra Singh
申办方类型
Other [PRINCIPAL INVESTIGATOR]

研究点 (1)

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