Data Collection of Normal Tissue Toxicity for Proton Therapy

Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:May 2005
End Date:September 2020
Contact:Steven J. Frank, MD

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Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults

The goal of this research study is to collect information on the side effects of proton
therapy and detailed information on the proton therapy treatment plan itself so that
researchers can develop methods to predict the risk of side effects for future patients.

This is an investigational study. Researchers expect to have about 5,000 patients on the
study. All the patients will be enrolled at MD Anderson.

As part of your standard of care, you will be examined by your doctor weekly during your
routine proton therapy and then 1-3 more times up to 90 days from the start of treatment and
then at least once a year after that.

Also as part of your standard of care, certain standard laboratory blood and/or urine test
and/or radiologic tests will be done to check if the tumor is under control and to look for
any side effect of the treatment.

If you agree to take part in this study, all of the information collected during your visits
as well as detailed information on the proton treatment plan will be gathered and stored in a
computer for future analysis.

You will fill out quality-of-life questionnaires that should take about 15-20 minutes to

Inclusion Criteria:

1. All patients scheduled for radiation treatment with protons at UTMDACC are eligible
for this protocol.

2. Patients must be 18 years of age or older (patients under 18 years of age will be
eligible for a similar pediatric protocol)

3. Patients must sign a study-specific consent form prior to study entry. A research
nurse/data coordinator will consent the patient at the earliest clinical appointment
if currently receiving treatment or when treatment begins. The research nurse/data
coordinator has undergone adequate training in the protection of human subjects.

Exclusion Criteria:

1. Patients who are unable or unwilling to attend the required periodic follow-ups either
at M.D.Anderson or at a different site.
We found this trial at
1515 Holcombe Blvd
Houston, Texas 77030
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Houston, TX
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