Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00167908
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Study Completion: 2007-05
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Local and regional tumor control