Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
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|ClinicalTrials.gov Identifier: NCT01165658|
Recruitment Status : Terminated (Requested by PI during yearly Continuing Review)
First Posted : July 20, 2010
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Small Cell Lung Cancer Carcinoid Thymic Cancer Lung Cancer||Radiation: Proton Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies|
|Actual Study Start Date :||July 16, 2010|
|Actual Primary Completion Date :||July 19, 2016|
|Actual Study Completion Date :||July 19, 2016|
Experimental: Proton Therapy
The radiation prescription dose ranges from 45 Gy in 3 Gy fractions to 60 Gy in 4 Gy fractions. Patients will be assigned to receive 1 of 3 doses of radiation therapy, based on when they joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.
Radiation: Proton Therapy
The regimen of 45 Gy in 15 fractions will be delivered as a baseline, and then the fraction size will be escalated in two different intervals of 0.5 Gy each, with the ultimate dose being 60 Gy in 4 Gy fractions.
- Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy [ Time Frame: 1 month after completion of radiation therapy ]Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.
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): NCT01165658
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Gomez, MD||M.D. Anderson Cancer Center|