NCT02292745已完成不适用
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Foundation for Liver Research2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2014年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytological or histologically confirmation of pancreatic cancer.
- •WHO performance status of 0 or 1
- •ASA classification I or II
- •Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy.
- •No evidence of metastatic disease
- •Largest tumor diameter < 7 cm x 7 cm x 7 cm
- •Normal renal function (Creatinine ≥ 30 ml/min).
- •Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)
- •Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l)
- •Age > 18 years and < 75 years
- •Written informed consent
排除标准
- •Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).
- •Lymph node metastases from primary tumor outside the field of radiation.
- •Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence.
- •Pregnancy, breast feeding.
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
结局指标
主要结局
overall survival
时间窗: up to 3.5 years after start of therapy
次要结局
- time to development of distant metastases(up to 3.5 years after start of therapy)
- number of toxicity events related to chemotherapy(up to 3.5 years after start of therapy)
- radiological response rates after chemotherapy and radiotherapy(up to 3.5 years after start of therapy)
- time to locoregional disease progression(up to 3.5 years after start of therapy)
- predictive value of a set of biological markers for treatment response(up to 3.5 years after start of therapy)
- number of resections at end of stereotactic radiotherapy(up to 3.5 years after start of therapy)
研究者
研究点 (2)
Loading locations...
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