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.
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
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
Single group
ConformalFLASH irradiation
RadiationSubjects 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.
ConformalFLASH treatment delivery feasibility
Delivery of ≥ 95% of the prescribed dose to ≥ 95% of the clinical target volume (CTV) at an average dose rate of ≥ 40 GyRBE/second
Acute toxicities
Incidence of acute toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
ConformalFLASH treatment delivery accuracy
Dose delivered to the clinical target volume (CTV) and organs at risk (OARs) as well as the average dose rate to the CTV
Late toxicities
Incidence of late toxicity as assessed by CTCAE version 6.0
Local Control
Absence of tumor recurrence or progression at the primary radiated disease site following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
Regional control
Absence of tumor recurrence or progression in regional lymph nodes following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
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IBA Proton Therapy, Inc.
Lead sponsor
University of Pennsylvania
Collaborator
