Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies
NCT00921739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2020-04-02
Summary
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.
Conditions
- Non Small Cell Lung Cancer
- Small Cell Lung Cancer
- Thymoma
- Thymus Neoplasms
Interventions
- 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).
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Christopher Kelsey, MD · Duke University Medical Center, Dept Radiation Oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-11
- Primary Completion
- 2014-12-31
- Completion
- 2016-11-30
Countries
- United States
Study Locations
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