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NCT Number: NCT07644585

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Pennsylvania, Department of Radiation Oncology

Philadelphia, Pennsylvania, 19104, United States

Location contact

Alexander Lin, MD

CONTACT

About this study

C-FLASH-01 is a pilot study evaluating the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) to participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection. Stereotactic Body Radiation Therapy (SBRT) re-irradiation is a standard approach that enables highly conformal dose delivery over a limited number of fractions. ConformalFLASH is an investigational approach that applies SBRT principles using proton therapy delivered at ultra-high dose rates (≥ 40 Gray Relative Biological Effectiveness (GyRBE)/second), with the potential to reduce normal tissue toxicity while maintaining tumor control. Participants will undergo treatment planning and delivery consistent with standard SBRT workflows. Treatment consists of five fractions (8 GyRBE per fraction) delivered over approximately 1.5 to 2 weeks. The primary objective is to assess the feasibility of delivering conformal proton SBRT at dose rates ≥ 40 GyRBE/second, along with evaluation of acute toxicity. Secondary objectives include assessment of treatment delivery accuracy, late toxicity, clinical outcomes, and patient-reported quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. ConformalFLASH treatment delivery feasibility

    Time frame: Through treatment completion (within 1 month after last fraction)

    Delivery of ≥ 95% of the prescribed dose to ≥ 95% of the clinical target volume (CTV) at an average dose rate of ≥ 40 GyRBE/second

  2. Acute toxicities

    Time frame: Up to 3 months after treatment start

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

Secondary outcomes

  1. ConformalFLASH treatment delivery accuracy

    Time frame: Through treatment completion (within 1 month after last fraction)

    Dose delivered to the clinical target volume (CTV) and organs at risk (OARs) as well as the average dose rate to the CTV

  2. Late toxicities

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

    Incidence of late toxicity as assessed by CTCAE version 6.0

  3. Local Control

    Time frame: 3 months and 1 year

    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

  4. Regional control

    Time frame: 3 months and 1 year

    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

  5. Metastasis-free survival

    Time frame: 3 months and 1 year

    Time from first treatment to the first occurrence of distant metastatic disease or death from any cause.

  6. Overall survival

    Time frame: 3 months and 1 year

    Time from first treatment to death from any cause

  7. Patient-reported quality of life

    Time frame: Up to 5 years

    Effect of the treatment on patient-reported quality of life, using the University of Washington Quality of Life Questionnaire (UW-QOL).The UW-QOL consists of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The UW-QOL comprises 12 single-question domains, each between 3 and 6 response options. These options are scaled evenly from 0 (worst) to 100 (best), according to the hierarchy of response. Each domain is scored individually, and an overall composite score can be derived.

    In addition, patients are asked to choose up to 3 of these domains that they consider most important to them. The UW-QOL also includes 3 global questions, one about how patient feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL.

Study contacts

Contact information is provided by the study sponsor or research team.

Sofie Gillis

CONTACT

[email protected]

+32 499 985 686

Sophie Le Bail

CONTACT

[email protected]

+32 470 226 032

Sponsors and collaborators

Lead sponsor

IBA Proton Therapy, Inc.

Industry

Collaborators

  • University of Pennsylvania

Registry information

Acronym: C-FLASH-01

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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