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RECRUITING
NCT04901234
PHASE2

Adaptive RadioTherapy for OroPharynx Cancer

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

Summary

This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.

Official title: Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-07-30

Completion Date

2026-12

Last Updated

2023-12-12

Healthy Volunteers

No

Interventions

RADIATION

Standard radiotherapy +/- chemotherapy

No radiotherapy adaptation unless major dosimetric deviation

RADIATION

Experimental radiotherapy +/- chemotherapy

Systemic MRI-based radiotherapy adaptation mid-treatment

Locations (2)

Austin Health

Melbourne, Australia

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada