Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 232
- 主要终点
- Overall Survival
研究概览
简要总结
The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
详细描述
DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
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
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
- •Clinical stage: cTNM: stage III
- •Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)
- •Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
- •Written informed consent
排除标准
- •Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
- •Distant metastases (including retroperitoneal lymph node)
- •Locally advanced inoperable disease (Clinical assessment)
- •Relapse of gastric cancer
- •Malignant secondary disease
- •Prior chemo or radiotherapy
- •Inclusion in another clinical trial
- •Known contraindications or hypersensitivity for planned chemotherapy
研究组 & 干预措施
NAC PLUS SURGERY
Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.
干预措施: Chemotherapy (Drug)
SURGERY FIRST
Patients undergo curative gastrectomy without any prior chemotherapy.
干预措施: Curative gastrectomy (Procedure)
结局指标
主要结局
Overall Survival
时间窗: Five years
Time from randomization to death from any cause
次要结局
- Percentage of Grade 3/4 hematological adverse events(Three months)
- Pathological response(Four months)
- Completion rate of planned NAC(Three months)
- Disease-free survival (DFS)(Two years)
研究者
BIRENDRA KUMAR SAH
Principal Investigator
Ruijin Hospital