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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Ethyol (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00167908

ETH018-01D

HSC 00-0885

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)