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Proton Beam Therapy for Chordoma Patients

2014-08-27 03:37:37 | BioPortfolio

Summary

Primary Objectives:

To establish the efficacy of proton beam therapy with or without photon beam radiation therapy for skull base chordoma.

Secondary Objectives:

1. To determine the patterns of failure of the treatment using dosimetric parameters

2. To measure and characterize the late effects of proton therapy treatment by conducting longitudinal neuroimaging, neuropsychological, neuro-endocrine, neuro-ophthalmological testing and audiometry.

Description

Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a magnetic resonance imaging (MRI) and computerized tomography (CT) scan of the skull base within 90 days before starting treatment. You will have neuropsychological testing and hearing and vision tests, including formal visual field testing. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk. Blood (about 1 teaspoon) will also be collected for routine tests. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are eligible to take part in this study, you will receive proton beam therapy no sooner than 2 weeks after the last surgery to remove the tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each day.

This is an investigational study. The proton beam machine used to deliver treatment is approved by the FDA for patient use. The doses being studied are experimental. About 15 participants will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chordoma

Intervention

Proton Beam Therapy, Proton Beam Therapy

Location

U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:37:37-0400

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