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

Active, not recruiting

• Conditions: Head and Neck Carcinoma
• Interventions: Other: Medical Chart Review; Other: Questionnaire Administration

• Registration Number: NCT01627093
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2012-01-06
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, medical chart review)	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.
Observational (questionnaire, medical chart review)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Overall survival analysis of proton therapy for head and neck malignancies	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States