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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01808677
First received: March 7, 2013
Last updated: August 23, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Non-Small Cell Lung Cancer
Other: Thoracic Reirradiation Registry

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 49
Study Start Date: June 2012
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808677

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Daniel Gomez, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01808677     History of Changes
Other Study ID Numbers: PA11-1193
Study First Received: March 7, 2013
Last Updated: August 23, 2016

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
NSCLC
Thoracic reirradiation
Proton beam therapy
PBT
Intensity modulated radiation therapy
IMRT
Registry
Data

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on March 23, 2017