Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- History of previous histologically or cytologically documented NSCLC, stage I-IV.
- Prior course of radiation therapy or concurrent chemoradiation at least 1 month prior to the current course of radiation therapy.
- Patients eligible to receive a second course of radiation therapy to the thorax, at the discretion of the treating physician.
- Patients receiving concurrent chemotherapy or targeted agents will be eligible for this protocol.
3.2 Exclusion Criteria:
- Life expectancy<3 months
- Pregnancy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Thoracic Reirradiation Registry
Data collection on patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy.
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Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of High-Grade Toxicity
Time Frame: 5 years
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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.
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5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Gomez, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA11-1193
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.