Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer

Stanford University2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2003年7月最近更新: 2010年6月2日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Stanford University
入组人数: 100
试验地点: 2
主要终点: Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

详细描述

The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

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 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Pancreatic tumors not to exceed 7.5 cm.
•Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met).
•Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA).
•Patients with metastatic disease may be treated if they are symptomatic from the primary tumor.
•Eastern Clinical Oncology Group performance status 0, 1 or 2.

排除标准

•Chemotherapy within 1 month of registration.

结局指标

主要结局

Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery

次要结局

未报告次要终点

研究者

发起方

Stanford University

申办方类型

Other

研究点 (2)

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