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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00495170 |
Purpose
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 Objective:
1. Improve median survival.
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Carboplatin Radiation: Proton Radiotherapy Drug: Paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) |
| Estimated Enrollment: | 65 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Proton Radiotherapy + Carboplatin + Paclitaxel
|
Drug: Carboplatin
2 AUC IV Weekly
Radiation: Proton Radiotherapy
2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).
Drug: Paclitaxel
50 mg/m^2 IV Weekly
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joe Y. Chang, MD, PhD | 713-563-2300 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Joe Y. Chang, MD, PhD | |
| Principal Investigator: | Joe Y. Chang, MD, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Joe Y. Chang, MD, PhD/Assistant Professor ) |
| Study ID Numbers: | 2004-0976 |
| Study First Received: | June 28, 2007 |
| Last Updated: | October 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00495170 |
| Health Authority: | United States: Institutional Review Board |
|
Non-Small Cell Lung Cancer Lung Cancer Proton Radiotherapy Proton Beam Paclitaxel |
Taxol Carboplatin Paraplatin NSCLC |
|
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |
