Trial Information

Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

Proton Therapy:

Proton therapy is a type of radiation that is designed to lower the amount of radiation
given to the healthy tissue around the tumor by using a more focused beam of radiation.

Radiation Dose Levels:

If you are found to be eligible to take part in this study, you will be assigned to receive
1 of 3 doses of radiation therapy, based on when you joined the study. The first group of
at least 3 participants will receive the lowest total radiation dose. If the first dose is
tolerated well by the first group of participants in this study, then the next group of
participants will receive the second, higher dose of radiation. If this dose is tolerated,
then a third group will be treated at the highest dose.

Practice Visit:

You will have a "practice" radiation visit to plan how the radiation will be given, about 1
week before therapy. This practice visit should take about 1-2 hours. At this visit, you
will have a CT scan of the chest that will be used by the study staff to plan your proton
therapy. A mold (made of the type of material used for casts) will also be made around your
body that will be used to help you remain still during radiation therapy. Marks will be
made on your skin to help position your body correctly for the radiation therapy. These
marks may be permanent or temporary. If temporary marks are washed off, they will be
replaced.

Proton Therapy Visits:

About 1 week after the practice radiation visit, you will begin receiving radiation therapy.
At each visit, you will lie down in the mold of your body that was made at the practice
visit, and you will be lined up for radiation therapy using the marks made on your skin at
the practice visit.

You will receive radiation therapy every weekday (Monday-Friday) for about 3 weeks. Each
radiation session should last about 45-60 minutes.

Study Tests:

Each week while you are receiving radiation therapy, you will be asked about any side
effects you may be having. Your medical history will be recorded, and you will have a
physical exam. If your doctor thinks it is needed, blood (about 2 tablespoons each time)
will be drawn for routine tests, and/or you may have CT scans to check the status of the
tumor.

Length of Therapy:

You will receive proton radiation therapy for about 3 weeks. The radiation therapy will be
stopped early if the disease gets worse or intolerable side effects occur.

Follow-up Visits:

About 6 weeks after your last dose of proton radiation, you will have a CT scan of the chest
(with a contrast agent, if possible) and a physical exam.

About 3 months after the first follow-up visit you will have a physical exam, lung function
tests, and either a PET/CT scan or CT scan of the chest to check the status of the disease.

Long-term Follow-up:

Every 3 months for the first 2 years after you finish proton therapy, every 6 months for the
next 3 years, and 1 time every year after that, you will be asked to return to the clinic
for follow-up tests. These tests may include lung function tests, imaging scans (such as a
CT or PET/CT scan), and/or an ECG. This will be up to your doctor.

This is an investigational study. At this time, it is considered investigational to give
proton radiation therapy at the dose schedule used in this study. This schedule is being
used for research purposes only.

Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.