Trial Information

FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients With Localized Esophageal Cancer After Chemoradiation

You have cancer of the esophagus and you and your doctor have agreed that you will have
treatment with chemoradiation to try to shrink the cancer. You will then have surgery to
remove any remaining tumor.

How well cancer of the esophagus responds to chemoradiation varies from person to person.
Currently, doctors cannot tell before surgery in which patients the chemoradiation will kill
all of the cancer, some of the cancer, or not much of the cancer. Studying patients' PET/CT
scans and tumor tissue for biomarkers may help researchers predict how an individual patient
will respond to chemoradiation. This could spare future patients from having unnecessary
surgery or chemoradiation treatment that is not effective.

PET and CT scans are both standard imaging tests that doctors use to find cancer in the
body. The PET scan detects the signal of actively growing cancer cells in the body and the
CT scan shows the location, size, and shape of the cancer. Combining these scans provides
more complete information on cancer location, growth, and changes in the cancer over time.

Currently, routine testing for esophageal cancer at MD Anderson includes a PET/CT scan at
the time of diagnosis and 5 or 6 weeks after chemoradiation is completed. Researchers hope
that analyzing changes seen in an "early" PET/CT scan (performed between 10-14 days after
starting chemoradiation) compared to the PET/CT scan taken at the time of diagnosis may
predict how well the chemoradiation will work against the patient's cancer.

PET/CT Scan:

If you are found to be eligible to take part in this study, 10-14 days after you start your
chemoradiation treatment you will have a PET/CT scan performed.

You will need to fast (not have anything to eat or drink except water) for 4-6 hours before
the PET/CT scan. Blood (about 1 teaspoon) will be drawn to check your blood sugar level.

You will receive a small amount of fluorodeoxyglucose (FDG) solution by vein. Cancer cells
use sugar at a higher rate than normal cells do. FDG is a radioactive form of glucose
(sugar) commonly used during a PET scan. The FDG helps show areas in the body where there
is cancer cell growth. After receiving the FDG solution, you will rest in a quiet, darkened
room for 45-60 minutes before the PET/CT scan. The entire procedure should take about 3
hours.

This PET/CT scan will be compared to your routine PET/CT scan. Your doctor will tell you of
the results of this PET/CT scan. However, the results will not change the planned treatment
you receive, unless the scan shows that the disease has gotten worse.

Biomarkers Testing:

Researchers will collected samples of tumor tissue previously collected at MD Anderson. This
tissue will be used for biomarker testing.

Length of Study:

You will be off active study once you complete the PET/CT scan.

Medical Record Information Collection and Long-Term Follow-Up:

The study staff will collect information from your medical record on tests, evaluations, and
treatments you receive as part of your routine care. The study staff will continue to
collect this information from your medical record as long as you are a patient at MD
Anderson.

If you stop coming to MD Anderson, you will be called by the study staff every 3 months
after surgery for the first year and then every 6 months after that. During this call, you
will be asked about your health status. The call should take about 5 minutes.

This is an investigational study. PET/CT scans are routine tests for patients with cancer
of the esophagus. The early PET/CT scan for the purpose of this study is investigational.

Up to 95 patients will take part in this study. All will be enrolled at MD Anderson.