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Trial record 1 of 1 for:    NCT01627093
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Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies

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ClinicalTrials.gov Identifier: NCT01627093
Recruitment Status : Recruiting
First Posted : June 25, 2012
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

This is an investigational study.

Up to 450 participants will take part in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment
Head and Neck Cancer Other: Chart Review Behavioral: Questionnaires

Detailed Description:

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.


Study Design

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
Actual Study Start Date : January 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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, 2017.
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


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival Analysis of Proton Therapy for Head and Neck Malignancies [ Time Frame: 7 years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants documented to have head and neck cancer treated with Proton Therapy at UT MD Anderson Cancer Center in Houston, Texas (MDACC) from January 1, 2008 through April 30, 2012, and participants who receive treatment from May 1, 2012 through December 31, 2017.
Criteria

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, 2017. Patient charts will be reviewed to determine pretreatment characteristics, time to progression and overall survival of patients.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627093


Contacts
Contact: Steven J. Frank, MD 713-563-2361

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01627093     History of Changes
Other Study ID Numbers: PA11-0803
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Head and Neck Malignancies
Chart Review
Proton Radiation Therapy

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site