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

NCT07644585 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IBA-04-UP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Proton Therapy; Ultra-High Dose-Rate

Outcome Measures

Primary Outcomes (2)

• 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

  Through treatment completion (within 1 month after last fraction)

• Acute toxicities

  Incidence of acute toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 6.0

  Up to 3 months after treatment start

Secondary Outcomes (7)

• ConformalFLASH treatment delivery accuracy

  Through treatment completion (within 1 month after last fraction)

• Late toxicities

  Beyond 3 months after start of treatment and up to 5 years

• Local Control

  3 months and 1 year

• Regional control

  3 months and 1 year

• Metastasis-free survival

  3 months and 1 year

Study Arms (1)

Treatment Arm

EXPERIMENTAL

ConformalFLASH irradiation

Radiation: ConformalFLASH irradiation

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Prior receipt of at least 45 GyRBE radiotherapy to the head and neck
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record
• Life expectancy of more than 12 weeks
• Ability to understand and the willingness to provide written informed consent and to follow the study procedures

You may not qualify if:

• 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
• Presence of distant metastatic disease
• Involvement of any of the following structures: skin, carotid artery, or mandible
• Receipt of concurrent chemotherapy during radiotherapy
• Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements
• Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT
• Pregnant and/or breastfeeding

Sponsors & Collaborators

• IBA Proton Therapy, Inc.: lead
• University of Pennsylvania: collaborator

Study Sites (1)

The University of Pennsylvania, Department of Radiation Oncology

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Vargo JA, Ferris RL, Ohr J, Clump DA, Davis KS, Duvvuri U, Kim S, Johnson JT, Bauman JE, Gibson MK, Branstetter BF, Heron DE. A prospective phase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):480-8. doi: 10.1016/j.ijrobp.2014.11.023. Epub 2015 Jan 30.

  PMID: 25680594 RESULT

• Heron DE, Ferris RL, Karamouzis M, Andrade RS, Deeb EL, Burton S, Gooding WE, Branstetter BF, Mountz JM, Johnson JT, Argiris A, Grandis JR, Lai SY. Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1493-500. doi: 10.1016/j.ijrobp.2008.12.075. Epub 2009 May 21.

  PMID: 19464819 RESULT

• Lartigau EF, Tresch E, Thariat J, Graff P, Coche-Dequeant B, Benezery K, Schiappacasse L, Degardin M, Bondiau PY, Peiffert D, Lefebvre JL, Lacornerie T, Kramar A. Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer. Radiother Oncol. 2013 Nov;109(2):281-5. doi: 10.1016/j.radonc.2013.08.012. Epub 2013 Nov 18.

  PMID: 24262821 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Alexander Lin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Le Bail

CONTACT

+32 470 226 032; sophie.lebail@iba-group.com

Sofie Gillis

CONTACT

+32 499 985 686; sofie.Gillis@iba-group.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)