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


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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
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 60 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



3.1.1 History of previous histologically or cytologically documented NSCLC, stage I-IV.

3.1.2 Prior course of radiation therapy or concurrent chemoradiation at least 1 month
prior to the current course of radiation therapy.

3.1.3 Patients eligible to receive a second course of radiation therapy to the thorax, at
the discretion of the treating physician.

3.1.4 Patients receiving concurrent chemotherapy or targeted agents will be eligible for
this protocol.

Exclusion Criteria:

3.2.1 Life expectancy <3 months 3.2.2 Pregnancy

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence of High-Grade Toxicity

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Daniel Gomez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

PA11-1193

NCT ID:

NCT01808677

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Thoracic reirradiation
  • Proton beam therapy
  • PBT
  • Intensity modulated radiation therapy
  • IMRT
  • Registry
  • Data
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030