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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00915005 |
The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
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Non-Small-Cell Lung Carcinoma |
Radiation: Photon Therapy Radiation: Proton Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Bayesian Randomized Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence |
Estimated Enrollment: | 168 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Group 1: Photon Therapy
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Radiation: Photon Therapy
Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete.
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Group 2: Experimental
Group 2: Proton Therapy
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Radiation: Proton Therapy
Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Group 3: 60-74 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. |
Group 3: Experimental
Group 3: Proton treatment at a lower dose level and/or reduced length of radiation
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Radiation: Proton Therapy
Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Group 3: 60-74 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zhongxing Liao, MD | 713-563-2300 |
United States, Massachusetts | |
Massachusetts General Hospital | Not yet recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77007 | |
Principal Investigator: Zhongxing Liao, MD |
Study Chair: | Zhongxing Liao, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Zhongxing Liao, MD / Associate Professor ) |
Study ID Numbers: | 2008-0133 |
Study First Received: | June 4, 2009 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00915005 History of Changes |
Health Authority: | United States: Institutional Review Board |
Locally-advanced non-small-cell lung carcinoma NSCLC Lung Cancer Image-Guided Adaptive Conformal Photon |
Proton Therapy Chemotherapy Treatment Related Pneumonitis |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Carcinoma, Non-Small-Cell Lung Recurrence Pneumonia Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |