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NCT00167908 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00167908
Other study ID # ETH018-01D
Secondary ID HSC 00-0885
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated February 3, 2009
Start date October 2001
Est. completion date May 2007

Study information
Verified date February 2009
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ethyol (drug)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary Salivary function at 6 months and yearly compared to pre-treatment salivary function
Secondary Local and regional tumor control
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