Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer
Information source: Washington University School of Medicine
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: Ethyol (drug) (Drug)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Wade Thorstad, M.D., Principal Investigator, Affiliation: Washington University Medical Center
Summary
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.
Clinical Details
Official title:
Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT
Study design: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Salivary function at 6 months and yearly compared to pre-treatment salivary function
Secondary outcome: Local and regional tumor control
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date:
October 2001
Last updated: September 9, 2005
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