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

February 3, 2009 updated by: Washington University School of Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

27

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Local and regional tumor control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Wade Thorstad, M.D., Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETH018-01D
  • HSC 00-0885

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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