Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT

Washington University School of Medicine0 个研究点目标入组 27 人开始时间: 2001年10月1日最近更新: 2009年2月4日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Washington University School of Medicine
入组人数: 27
主要终点: Salivary function at 6 months and yearly compared to pre-treatment salivary function

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.

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

入选标准

•Pathologically confirmed squamous cell cancer of the head and neck
•Eligible sites: oral cavity, oropharynx, hypopharynx, larynx.
•Patients requiring postoperative IMRT.
•KPS > 70%.
•Patient has signed specific protocol consent prior to registration.
•Calcium test within normal limits.
•No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years.
•Labs completed with 30 days of registration (CBC & platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation.
•Liver CT if alk phos, SGOT, or bili elevated.
•Bone scan if elevated alk phos

排除标准

•Metastatic disease.
•Patient using Salagen or concurrent chemotherapy.
•Previous XRT for head and neck tumors.
•Active untreated infection.

结局指标

主要结局

Salivary function at 6 months and yearly compared to pre-treatment salivary function

次要结局

Local and regional tumor control

研究者

发起方

Washington University School of Medicine

申办方类型

Other

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