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

This study has been completed.

First Received: September 9, 2005 Last Updated: February 3, 2009 History of Changes

Sponsor:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00167908

Purpose

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

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Ethyol (drug)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Local and regional tumor control

Estimated Enrollment:	27
Study Start Date:	October 2001
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167908

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Wade Thorstad, M.D.

Washington University Medical Center

More Information

No publications provided

Responsible Party:	Washington University ( Wade Thorstad, MD )
Study ID Numbers:	ETH018-01D, HSC 00-0885
Study First Received:	September 9, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00167908 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Radiation-Protective Agents
Neoplasms
Neoplasms by Site
Amifostine

Head and Neck Neoplasms
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010