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ACTIVE NOT RECRUITING
NCT03224000
PHASE2

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Official title: Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2018-01-17

Completion Date

2026-12-31

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

PROCEDURE

Modified Barium Swallow (MBS)

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

BEHAVIORAL

Swallowing Questionnaire

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

BEHAVIORAL

Symptom Questionnaire

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

PROCEDURE

Video-Strobe Procedure

Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

PROCEDURE

MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning

IMRT planned with MRI guidance.

PROCEDURE

Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning

IMRT planned by standard-of-care.

RADIATION

Intensity Modulated Radiotherapy (IMRT)

Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States