Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
If you agree to take part in this study, data will be recorded during your therapy. The
data to be recorded will include your medical history, the disease, treatments you have
received and how you have responded to any treatments, as well as any side effects you may
The data will be stored on a password-protected computer at MD Anderson for use in future
research related to cancer.
Your data will be given a code number. No identifying information will be directly linked
to your data. Only the researcher in charge of this study will have access to the code
numbers and be able to link the data to you. This is to allow medical information related
to your data to be updated as needed. Other researchers using your data will not be able to
link this data to you.
Length of Study After you sign this consent form, your active participation on this study
will be over.
This is an investigational study.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
Prevalence of High-Grade Toxicity
Primary objective to assess the prevalence of high-grade toxicity in patients being treated with thoracic reirradiation with proton beam therapy (PBT) or intensity modulated radiation therapy (IMRT) for non-small cell lung cancer (NSCLC), with or without chemotherapy. High-grade toxicity defined as CTCAE v4.0 Grade 3 or higher toxicity, or CTCAE v4.0 grade 4 or higher toxicity of the esophagus. Data collected from 1/2/2012 to 1/31/2017. High-grade toxicity rate and its corresponding 95% confidence interval provided at end of study. Logistic regression model used to assess the association between prognostic factors such as total dose to normal tissue structures, time since initial course of RT, failure in same lobe of the lung, failure in nodal regions, and central vs. peripheral location and high-grade toxicity.
Daniel Gomez, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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