Status:
COMPLETED
Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer
Lead Sponsor:
Washington University School of Medicine
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Metastatic disease.
- Patient using Salagen or concurrent chemotherapy.
- Previous XRT for head and neck tumors.
- Active untreated infection.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00167908
Start Date
October 1 2001
End Date
May 1 2007
Last Update
February 4 2009
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