Proton Therapy for Head and Neck Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01627093
First received: June 21, 2012
Last updated: February 25, 2014
Last verified: February 2014

June 21, 2012
February 25, 2014
January 2012
January 2016   (final data collection date for primary outcome measure)
Overall Survival Analysis of Proton Therapy for Head and Neck Malignancies [ Time Frame: 7 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01627093 on ClinicalTrials.gov Archive Site
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Proton Therapy for Head and Neck Malignancies
Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies

The goal of this data review research study is to collect medical record information from patients with head and neck cancer that have received or are scheduled to receive proton therapy at MD Anderson. Researchers will study the medical record information to try and improve therapy for future patients with head and neck cancer.

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. The questionnaires may be performed in person by mail, by phone or by secure electronic methods. The research coordinator will notify you via telephone, mail or via electronic notification approximately 2-3 weeks after the questionnaire is sent to remind you and also give you the option of performing the survey by other means.

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.

Observational
Observational Model: Cohort
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Probability Sample

Patients with diagnosis of head and neck cancer, treated with proton therapy from January 1, 2008 to December 31, 2014 at UT MD Anderson Cancer Center in Houston, Texas.

Head and Neck Cancer
  • Other: Chart Review
    Both retrospective and prospective patient charts reviewed to determine pretreatment characteristics, time to progression and overall survival of patients.
  • Behavioral: Questionnaires
    Completion of 5 questionnaires before treatment begins, at each visit during treatment, and again at all follow-up visits. It should take about 30 minutes to complete the questionnaires each time.
    Other Name: Surveys
Proton Therapy Chart Review
Retrospective and prospective chart analysis performed on all patients documented to have head and neck cancer treated with Proton Therapy at UT MD Anderson Cancer Center from January 1, 2008 through December 31, 2014.
Interventions:
  • Other: Chart Review
  • Behavioral: Questionnaires
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
275
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January 2016   (final data collection date for primary outcome measure)

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 April 30, 2012. We will prospectively consent patients who receive treatment from May 1, 2012 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

Both
18 Years and older
No
Contact: Steven J. Frank, MD 713-563-2361
United States
 
NCT01627093
PA11-0803
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Steven J. Frank, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP