临床试验/NCT02454140

NCT02454140已完成不适用

Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer

University of California, San Diego2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2014年6月20日最近更新: 2025年9月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of California, San Diego
入组人数: 30
试验地点: 2
主要终点: Maximum Tolerated Dose

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

This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.

详细描述

This trial is designed to find the maximum tolerated dose of radiation under a fixed 5-fraction SBRT regimen escalating the dose from 40 Gy in 5 fractions, to 60 Gy in 5 fractions, at 5 Gy intervals.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Other
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

•Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas.
•Disease Status: Medically unresectable (any stage), or locally advanced (stage III).
•Tumor Location: Primary tumor may be located anywhere in the pancreas.
•Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol.
•Performance Level: Karnofsky Performance Status ≥ 60
•Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal
•Informed Consent: All subjects must sign a written informed consent.

排除标准

•Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
•Life expectancy < 6 months
•The patient cannot have had prior radiation therapy to the thorax or upper abdomen.
•Incarcerated individuals
•Subjects unable to give informed consent

结局指标

主要结局

Maximum Tolerated Dose

时间窗: From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years

The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.

次要结局

未报告次要终点

研究者

发起方

University of California, San Diego

申办方类型

Other

责任方

Principal Investigator

主要研究者

James D. Murphy, MD, MS

Associate Clinical Professor, Radiation Medicine

University of California, San Diego

研究点 (2)

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