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NOT YET RECRUITING
NCT07644585
NA

A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck

Sponsor: IBA Proton Therapy, Inc.

View on ClinicalTrials.gov

Summary

This pilot study is designed to evaluate the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) in participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection. ConformalFLASH treatment planning and delivery workflows are comparable to those of conventional Stereotactic Body Radiation Therapy (SBRT), a standard approach for re-irradiation in this population.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-08

Completion Date

2032-12

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

RADIATION

ConformalFLASH irradiation

Subjects will be treated with SBRT (8 GyRBE x 5 fractions over 1.5-2 weeks), using pencil-beam scanning proton therapy, delivered at an average dose rate of ≥ 40 GyRBE/second, without chemotherapy.

Locations (1)

The University of Pennsylvania, Department of Radiation Oncology

Philadelphia, Pennsylvania, United States