NCT03322969Unknown2 期

Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy Versus Receiving the Original Chemotherapy in Locally Advanced Gastric Cancer: a Randomized Controlled Study

Peking Union Medical College Hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2017年8月23日最近更新: 2021年2月26日

研究概览

简要总结

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of <50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.

详细描述

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of <50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy. Overall survival and disease-free survival will be observed between two groups.

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

•TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;
•ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;
•age ≥18 years old;
•no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;
•gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;
•signed the informed consent form.

排除标准

•All do not reach the inclusion criteria

研究组 & 干预措施