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Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

NCT00409331 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2012-08-07

Study results available
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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.

Conditions

Interventions

DRUG

Amifostine

500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.

PROCEDURE

Intensity- Modulated Radiation Therapy

2.0 to 2.2 Gy delivered in 30 fractions

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Mark Chambers, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409331 on ClinicalTrials.gov