Clinical trial NCT01808677: Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
Official title: Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
Thoracic reirradiation
Proton beam therapy
PBT
Intensity modulated radiation therapy
IMRT
Registry
Data
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of High-Grade Toxicity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Daniel Gomez, MD
role: PRINCIPAL_INVESTIGATOR
References: