Trial Information

Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy

One of the ways to learn about the symptoms of chemoradiation therapy is by looking at how
certain proteins called cytokines (found in the blood) change during therapy. Another way
is to look at how thinking and memory may be changed because of treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit
to the Radiation Oncology clinic at M. D. Anderson. These questionnaires measure physical
and emotional symptoms. These questionnaires should take about 30 minutes to finish. Lung
cancer patients will also complete some cognitive (mental) questionnaires. During this
visit, the research nurse will teach you how to use the telephone system for measuring
symptoms. You will tell the system the most convenient times for the telephone calls. The
date of the call will be at the same or close to the date of your weekly clinic visit.

Before you begin your chemoradiation treatments, you will have a sample of blood drawn
(around 2½ tablespoons). The sample of blood will be used to measure levels of cytokines in
your blood pre treatment.

You will have about 2½ tablespoons of blood drawn again when you start chemoradiation, and
then once a week while you are receiving treatment. These cytokines may be related to
symptoms experienced while having treatment for cancer. These blood tests are being done to
study the levels of cytokines in your blood during, and after treatment for cancer.

Symptoms will be monitored weekly using an interactive voice response telephone system.
During chemoradiation, the automated telephone system will call you once a week to ask you
to rate your symptoms and how much the symptoms interfere in your daily life. The
information collected by these calls is only being used for this research study.

At the end of the chemoradiation, lung cancer patients will again be given questionnaires to
measure cognitive symptoms.

For lung cancer patients who are post-chemotherapy, your symptoms will be monitored weekly
for 3 months after therapy using the interactive voice response telephone system. For
esophageal, gastric, colorectal, and anal patients who are post-therapy, your symptoms will
be monitored weekly for 6 weeks after therapy using the interactive voice response telephone
system. About 30 days after chemoradiation, you will have 2½ tablespoons of blood drawn at
your regularly scheduled clinic visit. If you are not scheduled for a 3 month clinic visit,
we will contact your local physician for blood lab results.

This is an investigational study. About 225 evaluable patients will take part in this
study. All will be enrolled at M. D. Anderson.