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

This study has been completed.
Information provided by:
Washington University School of Medicine Identifier:
First received: September 9, 2005
Last updated: February 3, 2009
Last verified: February 2009
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00167908

Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Wade Thorstad, M.D. Washington University School of Medicine
  More Information

Responsible Party: Wade Thorstad, MD, Washington University Identifier: NCT00167908     History of Changes
Other Study ID Numbers: ETH018-01D
HSC 00-0885
Study First Received: September 9, 2005
Last Updated: February 3, 2009

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs processed this record on September 21, 2017