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Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies


If you agree to take part in this study, information will be collected from your medical
records that is related to your personal medical history, diagnosis, and the treatment you
received or are scheduled to receive for head and neck cancer. The information from your
medical record will be collected at least 1 time, however, the study doctor may collect
additional information from your medical records at any time in the future for the purposes
of this study.

You will complete 5 questionnaires before your treatment begins, at each visit during your
treatment, and again at all follow-up visits related to your treatment. It should take about
30 minutes to complete the questionnaires each time.

All information that is collected for this study will be stored in a password-protected
computer and database at MD Anderson for use in future research related to cancer.

Your medical record information will be given a code number. No identifying information
will be directly linked to your medical record information. Only the researcher in charge
of the password-protected computer and database will have access to the code numbers and be
able to link your medical record information back to you. This is to allow medical data
related to your medical record information to be updated as needed. Other researchers using
your medical record information from the password-protected computer and database will not
be able to link any information back to you.

Length of Study After you sign this consent form, your active participation in this study
will be over. Your medical record information may be collected indefinitely.

This is an investigational study.

Up to 250 participants will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1) Retrospective chart analysis will be performed on all patients documented to have head
and neck cancer treated with Proton Therapy at MDACC from January 1, 2008 through August
31, 2011. We will prospectively consent patients who receive treatment from September 1,
2011 through December 31, 2014. Patient charts will be reviewed to determine pretreatment
characteristics, time to progression and overall survival of patients.

Exclusion Criteria:

N/A

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Overall Survival Analysis of Proton Therapy for Head and Neck Malignancies

Outcome Description:

Chart analysis performed on all patients documented to have head and neck cancer treated with proton therapy from January 1, 2008 through December 31, 2014. Overall survival estimated using Kaplan-Meier method. Cox proportional hazards regression used to explore predictors of time-to-event outcomes. Mann-Whitney test used to compare continuous parameters between temporal cohorts.

Outcome Time Frame:

7 years

Safety Issue:

No

Principal Investigator

Steven J. Frank, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

PA11-0803

NCT ID:

NCT01627093

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Head and Neck Malignancies
  • Chart Review
  • Proton Radiation Therapy
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030