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
Locations
1Sponsors and collaborators
IBA Proton Therapy, Inc.
Lead sponsor
University of Pennsylvania
Collaborator