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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00167908
• Collaborator: (none)
• Enrollment: 27
• Duration (Months): 67

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Ethyol (drug)	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT
• Study Start Date: Oct 1, 2001
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Salivary function at 6 months and yearly compared to pre-treatment salivary function []

Secondary Outcome Measures

1. Local and regional tumor control []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Wade Thorstad, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00167908
• Other Study ID Numbers: ETH018-01D; HSC 00-0885
• First Posted: Sep 14, 2005
• Last Update Posted: Feb 4, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Head and Neck Neoplasms; Amifostine

Study Results

No Results Posted as of Feb 4, 2009