Proton Therapy for Head and Neck Malignancies
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Other: Chart Review Behavioral: Questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies |
- 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.
| Estimated Enrollment: | 275 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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
|
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations| Contact: Steven J. Frank, MD | 713-563-2361 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Steven J. Frank, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01627093 History of Changes |
| Other Study ID Numbers: | PA11-0803 |
| Study First Received: | June 21, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 19, 2013