A Non-Randomized,Single Center Study to Investigate the Real World Evidence for the Maximal Cycle of Effective Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The cycle of neoadjuvant chemotherapy
研究概览
简要总结
The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.
详细描述
The study is a non-randomized clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. MRI and enhanced CT are used to evaluate the clinical response of the tumor. The primary endpoint is the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the stomach
- •Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy.
- •Receive neoadjuvant chemotherapy in clinical
排除标准
- •Contraindication for chemotherapy
- •Contraindication for surgery
- •Clinically apparent distant metastasis
研究组 & 干预措施
experiment group
Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
干预措施: NACT (Drug)
experiment group
Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
干预措施: SDM (Procedure)
experiment group
Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
干预措施: Surgery (Procedure)
experiment group
Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
干预措施: ACT (Drug)
experiment group
Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy.
干预措施: Questionnaire (Other)
结局指标
主要结局
The cycle of neoadjuvant chemotherapy
时间窗: 18months
The cycle of neoadjuvant chemotherapy means the maximal cycle of effective neoadjuvant chemotherapy. The effective means no disease progress by image diagnosis
次要结局
- The completion rate of perioperative chemotherapy(18 months)
- Surgical morbidity(18 months)
- The cTNM,ycTNM,ypTNM stage(60months)
- The progressive disease rate(18 months)
- The clinical response rate(18 months)
- The pathological response(18 months)
- The pathological complete response(18months)
- The adverse event of chemotherapy(18 months)
- The decisional conflicts(12months)
- The decisional regrets(12months)
- The involvement of patients during the shared decision making(12months)
- The 3-year progression-free survival(48months)
研究者
Ziyu Li
Chief Physician, Professor
Peking University