Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies (ESIMRT)
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|ClinicalTrials.gov Identifier: NCT00921739|
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : January 11, 2019
Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy to 74 Gy given as 6 fractions/week with concurrent chemotherapy.
Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.
Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at high risk of developing esophageal toxicity from radiation therapy and chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Small Cell Lung Cancer Thymoma Thymus Neoplasms||Radiation: Esophageal sparing IMRT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Study of Accelerated Fractionation With Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esophageal Injury|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||November 2016|
Experimental: IMRT concurrent with chemotherapy
6 fractions of esophageal sparing IMRT weekly for 5-6 weeks (dependent on dose cohort) concurrent with standard chemotherapy: Cisplatin 50 mg/m2 /d intravenously (IV) on days 1, 8, 29, and 36. Etoposide 50 mg/m2 /d IV on days 1 through 5 and 29 through 33.
Radiation: Esophageal sparing IMRT
6 fractions/week of 2Gy each for 29 fx (58 Gy), 31 fx (62 Gy), 33 fx (66 Gy), 35 fx (70 Gy), or 37 fx (74 Gy).
- Maximum tolerated dose (MTD) of IMRT [ Time Frame: within 30 days of completing RT ]
- The occurrence of RT-induced acute esophagitis [ Time Frame: One year ]
- To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy [ Time Frame: Two years ]Blood will be drawn at specific time intervals, plasma will be analysed for Glutathione Oxidation, Citrulline, Lipid peroxidation, DNA oxidation, and Tetrahydrobiopterin.
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): NCT00921739
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Christopher Kelsey, MD||Duke University Medical Center, Dept Radiation Oncology|