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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIBA Proton Therapy, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits

Patients ≥ 18 years old

Patients ineligible for or decline upfront surgical resection

Histologically confirmed diagnosis of carcinoma of the head and neck

Disqualifiers

Receipt of prior head and neck radiotherapy within the prior 6 months

Surgical resection of the current disease in the head and neck

More than 3 areas of disease requiring reirradiation

Disease focus exceeding 6.5 cm in greatest dimension

Trial design

Treatments tested in this trial

  • ConformalFLASH irradiation

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

1
The University of Pennsylvania, Department of Radiation Oncology19104, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

IBA Proton Therapy, Inc.

Lead sponsor

University of Pennsylvania

Collaborator