Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01627093|
Recruitment Status : Recruiting
First Posted : June 25, 2012
Last Update Posted : September 14, 2017
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|
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 Type :||Observational|
|Estimated Enrollment :||450 participants|
|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|
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.
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
- 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.
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
|Contact: Steven J. Frank, MD||713-563-2361|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Steven J. Frank, MD||M.D. Anderson Cancer Center|