Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Increase overall survival
研究概览
简要总结
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.
详细描述
The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically or cytologically proven carcinoma of the pancreas that is locally advanced
- •ECOG performance status 0- 2
- •Adequate labs
- •No prior abdominal radiation therapy
- •No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
- •All disease must be encompassed within a radiotherapy portal
- •Not pregnant or nursing
排除标准
- •Patient has metastatic disease on radiological staging
- •systemic therapy.
- •Patient has known active infection with HIV, hepatitis C or hepatitis B
- •Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
- •Patient is deemed to be have obvious resectable disease at presentation
- •Received any investigational agent within a month prior to enrollment.
- •Neuroendocrine tumors of the pancreas
研究组 & 干预措施
Gemzar/Abraxane and Radiation Therapy
Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
干预措施: Gemcitabine (Drug)
Gemzar/Abraxane and Radiation Therapy
Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
干预措施: Abraxane (Drug)
Gemzar/Abraxane and Radiation Therapy
Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Increase overall survival
时间窗: 23 months
Estimated increase in median survival from 11 to 16 months
次要结局
- Rate of local control(baseline to average up to 24 weeks)
研究者
Olugbenga Olowokure
Assistant Professor
University of Cincinnati