A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 77
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall clinical response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks.
Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
干预措施: fluorouracil (Drug)
Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall Survival
时间窗: 9 months up to 3 years post treatment
次要结局
- Time to progression(After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs)
- Clinical Response(q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs)
- CA19-9 Levels(q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs)
- Toxicity(q cycle)