Trial Information

Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) Non-Small Cell Lung Cancer (NSCLC)

A proton beam is made up of charged particles that have a well-defined range of penetration
into tissues. How deep it can penetrate is decided by both the beam's energy and the
density of the tissue through which it passes. As the proton beam penetrates the body, the
particles slow down, and the beam deposits its dose sharply near the end of its range. This
is a phenomenon known as the Bragg peak. By adjusting the Bragg peak, the doctor can deliver
a full, localized, uniform dose of energy to the treatment site while sparing the
surrounding normal tissues. The proton beam is ideal for treatments where organ preservation
is very important, such as lung cancer. Researchers know that standard photon radiotherapy
is not able to adequately control tumor growth. But unfortunately, it is not possible to
increase the dose of photon radiotherapy without also significantly increasing the side
effects. In this study, using proton radiotherapy, researchers will increase the dose about
40% higher than standard photon radiotherapy.

Screening Tests

Signing this consent form does not mean that you will be able to take part in this study.
You will have "screening tests" to help the doctor decide if you are eligible to take part
in this study. The following tests and procedures will be performed before starting
treatment on this study:

Your complete medical history will be recorded. You will have a physical exam. Blood (about
4 teaspoons) will be drawn (within 30 days) for the routine blood tests You will have a
computed tomography (CT) scan or positron emission tomography (PET/CT) scan of the chest, an
MRI scan or CT of the brain, You will have a lung function test. Women who are able to have
children must have a negative blood-pregnancy test. You will have a 4DCT.

Study Drug Administration If you are found to be eligible to take part in this study, you
will receive 35 treatments of proton radiotherapy (radiotherapy does not have to start on a
Monday but it cannot start on a Friday; usually Monday through Thursday for 7 to 8 weeks).
During the treatment, you will lie still on a table for about 30-45 minutes per day in the
same position. The proton machine will deliver the dose according to the plan designed by
the physician and controlled by a computer. You will not feel, see, or smell anything during
the proton beam delivery.

During the treatment, you will be seen by a doctor and research nurse once a week to
evaluate possible side effects. You will have a physical exam and you will have a medical
history.

You will be taken off study early if the disease gets worse or intolerable side effects
occur. After finishing the treatment, follow up is recommended 6 weeks after completion of
radiotherapy, required every 3 months (+/-1 month) for two years, then every (+/-1 month) 6
months for three years, and then once a year for 2 years. You will have imaging tests
(chest CT or PET scan), lung function test and routine blood tests (about 2 teaspoons) at
the follow-up visits. You are allowed to have further chemotherapy or other treatment while
you are still in the follow-up on this study. You should discuss chemotherapy with your
medical oncologist.

This is an investigational study. Proton radiotherapy is FDA approved for the treatment of
lung cancer treatment. Up to 40 patients will take part in this study. All will be enrolled
at M. D. Anderson.