NCT00191568已完成2 期
A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study
研究概览
简要总结
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed adenocarcinoma of the pancreas
- •Patient have undergone a potentially curative resection
- •No previous irradiation to the planned field
- •Negative pregnancy test for child bearing women
排除标准
- •Non-adenocarcinoma pancreatic cancer
- •Treatment with any drug within the last 30 days that has not received regulatory approval.
- •Serious systemic disorder
- •Metastatic disease
- •Pregnancy, breast feeding
结局指标
主要结局
To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study
次要结局
- To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)
研究者
研究点 (6)
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