Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer
Phase 2
Completed
- Conditions
- Registration Number
- NCT00167908
- Lead Sponsor
- Washington University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
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Exclusion Criteria
- Metastatic disease.
- Patient using Salagen or concurrent chemotherapy.
- Previous XRT for head and neck tumors.
- Active untreated infection.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Salivary function at 6 months and yearly compared to pre-treatment salivary function
- Secondary Outcome Measures
Name Time Method Local and regional tumor control