Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To determine if amifostine in combination with IMRT can mitigate the decrease in production
of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.
Secondary Objectives:
1. To establish a parotid gland dose volume histogram (DVH) versus measured flow
relationship in this patient population:
- When the mean dose is < 24-26 Gy (shift recovery time to left)
- When the mean dose is > 24-26 Gy (DVH shift)
2. To observe mucositis in the following lower dose RT areas:
- Upper lip
- Lower lip
- Right cheek
- Left cheek
- Right ventral and lateral tongue
- Left ventral and lateral tongue
- Floor of the mouth
- Soft palate
- Hard palate.
3. To observe the incidence and patterns of occipital scalp epilation;
4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS);
and
5. To further evaluate the safety profile of amifostine in this patient population.