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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Amifostine

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.