NCT01050426终止2 期
A Multicentre Randomised Phase II Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- One year overall survival, measured from the date of registration.
研究概览
简要总结
The purpose is to assess the overall survival of patients receiving either UFT/LV + radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.
详细描述
Locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of CRT over chemotherapy alone. 4 Phase II- III studies patients without disease progression after 3 months of systemic chemotherapy and CRT had a longer survival than those continuing on chemotherapy. Therefore chemotherapy followed by CRT may be a better approach. Also the effect of blocking EGFR will be evaluated in locally advanced pancreatic cancer. Gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas.
- •Considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence, direct involvement of SMA, coeliac axis, inferior vena cava or aorta.
- •Performance status 0-2
- •No evidence of metastatic disease as determined by CT scan/ other investigations
- •Adequate bone marrow function with platelets>100^9/l; WBC>3x10^9/l;neutrophils> 1.5x10^9/l
- •Serum bilirubin ,1.5 x ULN and transaminases < 2.5 x ULN
- •Calculated/measured GFR >50ml/min
- •No concurrent uncontrolled medical condition
- •No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years
- •Life expectancy > 3months
- •Adequate contraceptive precautions
- •Informed written consent
排除标准
- •medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •Presence of met. disease
- •Concurrent uncontrolled medical conditions
- •Any previous chemo/RT or any investigational treatment for advanced pancreatic cancer.
- •Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry
- •Adjuvant RT with/without chemo for pancreatic cancer.
- •Pregnancy/breast feeding
- •Patients with known malabsorption syndromes ro a lack of physical treatment of the upper GI tract.
- •Patients with a known hypersensitivity to 5-FU or with a DPD deficiency.
- •Clinically significant CVD
研究组 & 干预措施
Group 1
Active Comparator
UFT/LV + RT
干预措施: UFT, Leucovorin (Other)
Group 2
Active Comparator
UFT/LV + RT + Cetuximab
干预措施: UFT/ Leucovorin + Cetuximab + Radiotherapy (Other)
结局指标
主要结局
One year overall survival, measured from the date of registration.
时间窗: one year
次要结局
- Objective response rate(three years)
- Quality of life(up to 3 years)
- Evaluation of the role of FDG-PET in predicting overall survival, progression free survival and objective response rate in locally advanced pancreatic cancer.(up to 3 years)
- Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer(three years)
- Pattern of failure(up to 3 years)
- Evaluation of molecular and genetic predictors of response to anti-EGFR treatment(up to 3 years)
- Progression free survival(three years)
- Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.(up to 3 years)
研究者
研究点 (8)
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