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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00167908
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Ethyol (drug) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
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
Study Start Date : October 2001
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Salivary function at 6 months and yearly compared to pre-treatment salivary function

Secondary Outcome Measures :
  1. Local and regional tumor control

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167908


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

Responsible Party: Wade Thorstad, MD, Washington University
ClinicalTrials.gov Identifier: NCT00167908     History of Changes
Other Study ID Numbers: ETH018-01D
HSC 00-0885
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs