Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy

August 23, 2016 updated by: M.D. Anderson Cancer Center
The goal of this research study is to learn more about the safety of treating NSCLC with reirradiation using standard methods and to look for ways to lessen side effects and improve therapy. Reirradiation is when radiation is given to an area of the body that has previously received a full dose of radiation.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being treated with thoracic reirradiation with PBT or IMRT for NSCLC, with or without chemotherapy at UT MD Anderson Cancer Center in Houston, Texas.

Description

Inclusion Criteria:

  1. History of previous histologically or cytologically documented NSCLC, stage I-IV.
  2. Prior course of radiation therapy or concurrent chemoradiation at least 1 month prior to the current course of radiation therapy.
  3. Patients eligible to receive a second course of radiation therapy to the thorax, at the discretion of the treating physician.
  4. Patients receiving concurrent chemotherapy or targeted agents will be eligible for this protocol.

3.2 Exclusion Criteria:

  1. Life expectancy<3 months
  2. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Daniel Gomez, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

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.

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