Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsored by:	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

MedlinePlus related topics:

Cancer Head and Neck Cancer Salivary Gland Disorders

ChemIDplus related topics:

Amifostine

U.S. FDA Resources

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

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

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

Study ID Numbers:	ETH018-01D, HSC 00-0885
First Received:	September 9, 2005
Last Updated:	September 9, 2005
ClinicalTrials.gov Identifier:	NCT00167908
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Amifostine

Head and Neck Neoplasms

Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 07, 2008