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Active, Not Recruiting

NCT Number: NCT01627093

Medical Data Collection of Patients With Head and Neck Cancer Treated With Proton Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

Review of medical records

Other names: Chart Review

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies

Important dates

Study start
2012
Primary completion
2032
Study completion
2032
First posted
Jun 25, 2012
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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