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临床试验/NCT01197118
NCT01197118Unknown2 期

Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

chemotherapy alone following radical resection

干预措施: chemotherapy alone following radical resection (Drug)

1

Experimental

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

研究者

研究点 (1)

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