Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B 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.
If you are found to be eligible to take part in this study, you will receive 37 treatments
of proton radiotherapy (Monday through Friday for 7 1/2 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.
While on study, you will also be receiving weekly standard low-dose chemotherapy possibly
followed by full-dose chemotherapy.
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. About 2 teaspoons of blood will be drawn for routine tests.
You will be taken off study early if the disease gets worse or intolerable side effects
occur. After finishing the treatment, 6 week follow up is recommended after completion of
radiotherapy, then required every 3 months (+1 month) for 2 years, then every 6 months (+1
month) for 3 years, and then once a year for 2 years. You will have imaging tests (chest CT
or PET scan) and routine blood tests (about 2 teaspoons) at the follow-up visits.
This is an investigational study. Proton radiotherapy is FDA approved for the treatment of
lung cancer. A total of 65 patients will be take part in this study. All will be enrolled
at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Survival Time
Median survival time defined as baseline to disease progression.
Follow for 2 Years
Joe Y. Chang, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|