Proton Radiotherapy for Patients With 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.

Inclusion Criteria:

1. Histologically or cytologically documented NSCLC.

2. Patients with inoperable centrally located tumors, defined as those within 2 cm of the
bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but
no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0
(selected stage II with chest wall involvement) NSCLC.

3. Performance score KPS 60-100.

Exclusion Criteria:

1. Prior radiotherapy to the chest.

2. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ
of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial
transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated
more than 3 years ago for cure.

3. Pregnancy. Patients, both men and women of child bearing potential should use an
effective method of birth control throughout their participation in this study.