Clinical trial NCT00495170
Conditions: Lung Cancer
Keywords: Non-Small Cell Lung Cancer Lung Cancer Proton Radiotherapy Proton Beam Paclitaxel Taxol Carboplatin Paraplatin NSCLC
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-04-14; Completion date: 2017-06-14
Enrollment: 84 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.

Detailed description:
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 positron emission computed tomography (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.

Arms: arm 1: Proton Radiotherapy + Carboplatin + Paclitaxel
Interventions: intervention 1: Carboplatin intervention 2: Proton Radiotherapy intervention 3: Paclitaxel
Intervention descriptions: intervention 1: 2 area under curve (AUC) by vein Weekly intervention 2: 2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks). intervention 3: 50 mg/m\^2 by vein Weekly

Protocol documents:
Prot_SAP_000.pdf: