Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains poor despite potentially curative resections. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, even after a complete resection with negative margins, many patients will experience recurrence. In recent years, the radiation therapy in the carcinoma of the stomach represents a new issue that should be addressed accompanying the development of radial physics and radial biology, the clinical application of computed tomographic (CT) simulation and digital reconstitution technique, especially the application of 3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to cause a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival for 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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
- •Age of 18 to 75, Karnofsky score higher than
- •Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, with or without positive incisal margin.
- •No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
- •No clinical findings of distant metastasis.
- •Predictive survival time longer than 6 months.
排除标准
- 未提供
研究组 & 干预措施
2
chemotherapy alone following radical resection
干预措施: chemotherapy alone following radical resection (Drug)
1
sequence chemoradiotherapy following radical resection
干预措施: sequence chemoradiotherapy (Radiation)
结局指标
主要结局
overall survival
时间窗: 1 year
次要结局
未报告次要终点
