- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627093
Medical Data Collection of Patients With Head and Neck Cancer Treated With Proton Therapy
October 5, 2023 updated by: M.D. Anderson Cancer Center
Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy.
Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy.
OUTLINE:
Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.
Study Type
Observational
Enrollment (Actual)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients documented to have head and neck cancer treated with proton therapy at MD Anderson Cancer Center in Houston, Texas (MDACC) from January 1, 2008 through April 30, 2012, and patients who receive treatment from May 1, 2012 through December 31, 2018
Description
Inclusion Criteria:
- Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (questionnaire, medical chart review)
Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment.
Patients also have their medical records reviewed.
|
Review of medical records
Other Names:
Complete questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival analysis of proton therapy for head and neck malignancies
Time Frame: 7 years
|
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.
Prospective chart analysis will be performed on head and neck cancer patients currently being treated at MD Anderson Cancer Center beginning May 1, 2012 through December 31, 2018.
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.
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven J Frank, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2012
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimated)
June 25, 2012
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- PA11-0803 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-00578 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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