Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.
详细描述
Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
- •Age ≥18 years old
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •Body mass index ≥ 18
- •No prior chemotherapy or chemoradiotherapy
- •TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
- •No evidence of metastasis (M0)
- •Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
排除标准
- •Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
- •Patients with evidence of severe or uncontrolled systemic disease
- •Medically unfit for chemotherapy
结局指标
主要结局
Disease Free Survival
时间窗: From date of diagnosis until treatment failure, assessed up to 10 years
DFS was defined as the time from diagnosis to the first date of local or distant cancer. Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
Overall Survival
时间窗: From date of diagnosis until death, assessed up to 10 years
Overall survival was defined as the period from diagnosis until death (from any cause). Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
次要结局
- Pathological Response at the Time of Surgery(Weeks 10 to 28)
- R0 Resection rate at the Time of Surgery(Weeks 10 to 28)
- Tumor Regression Grade at the Time of Surgery(Weeks 10 to 28)
- Lymph nodes response at the Time of Surgery(Weeks 10 to 28)
- Estimate of TN Change From Baseline to Surgery(Weeks 10 to 28)