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NCT01627093 Clinical Trial

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

Head and Neck Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01627093
Other study ID # PA11-0803
Secondary ID NCI-2020-00578PA
Status Active, not recruiting
Phase
First received
Last updated
Start date January 6, 2012
Est. completion date April 30, 2026

Study information
Verified date May 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 450
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Medical Chart Review
Review of medical records
• Questionnaire Administration
Complete questionnaires

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival analysis of proton therapy for head and neck malignancies 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
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Completed NCT02369835 - Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy Phase 3
Completed NCT03902535 - Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
Recruiting NCT05526924 - Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer Phase 1
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