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

NCT ID: NCT01808677

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Thoracic Reirradiation Registry

Intervention Type OTHER

Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

1. Life expectancy\<3 months
2. Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Gomez, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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PA11-1193

Identifier Type: -

Identifier Source: org_study_id

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