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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
IBA Proton Therapy, Inc.
Study ID
NCT07644585
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ConformalFLASH irradiation — RADIATION
    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.

Study Details

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 Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    ConformalFLASH irradiation

Primary Outcome Measure

ConformalFLASH treatment delivery feasibility [ Time Frame: Through treatment completion (within 1 month after last fraction) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Pennsylvania, Department of Radiation OncologyPhiladelphiaPennsylvania19104
Alexander Lin, MD

Find similar trials in Philadelphia, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of Pennsylvania, Department of Radiation Oncology· Philadelphia, PA

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