Radical Pleurectomy/Decortication (PD) and Intensity Modulated Radiotherapy (IMRT)
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|ClinicalTrials.gov Identifier: NCT01134146|
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Mesothelioma||Radiation: IMRT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Intensity Modulated Radiotherapy (IMRT) for Malignant Pleural Mesothelioma After Radical Pleurectomy/Decortication (PD)|
|Actual Study Start Date :||May 27, 2010|
|Actual Primary Completion Date :||July 9, 2017|
|Actual Study Completion Date :||July 9, 2017|
Experimental: Intensity Modulated Radiation Therapy (IMRT)
Intensity Modulated Radiation Therapy (IMRT) Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
Other Name: Intensity modulated radiation therapy
- Maximum Tolerated Dose (MTD) of IMRT after radical pleurectomy/decortication (PD) [ Time Frame: 3 Months ]MTD by assessing the toxicity of two different whole-pleura radiation doses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134146
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Daniel Gomez, MD||M.D. Anderson Cancer Center|