Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01808677|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : August 24, 2016
|Condition or disease||Intervention/treatment|
|Non-Small Cell Lung Cancer||Other: Thoracic Reirradiation Registry|
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 have had.
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 120 patients will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||49 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Thoracic Reirradiation Registry
Data collection on patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy.
Other: Thoracic Reirradiation Registry
Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes.
- Prevalence of High-Grade Toxicity [ Time Frame: 5 years ]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.
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): NCT01808677
|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|