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Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

2014-08-27 03:37:39 | BioPortfolio

Summary

Objectives:

- To assess therapeutic efficacy and toxicities of proton radiotherapy with concurrent chemotherapy for patients with inoperable stages IIIA/B non-small cell lung cancer (NSCLC).

Primary goal: Improve median survival.

Secondary goals:

1. Improve local control, progression free survival, disease specific survival and disease free survival.

2. Decrease grade 3 and above toxicities.

3. Pre- and post treatment PET/CT in predicting clinic outcome.

4. Biomarker for predicting treatment response and toxicities.

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.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide what is the stage of your disease and if you are eligible to take part in the study. You will have a CT scan or PET/CT scan of the chest, an MRI of the brain, a PET scan, and lung function test. About 4 teaspoons of blood will be collected for routine tests. Women who are able to have children must have a negative blood-pregnancy test.

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 M. D. Anderson.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

Carboplatin, Proton Radiotherapy, Paclitaxel

Location

U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:37:39-0400

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Medical and Biotech [MESH] Definitions

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

The use of an external beam of PROTONS as radiotherapy.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

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