Head and Neck CancerC-FLASH-01NCT07644585
A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck
A study testing ConformalFLASH irradiation in people with Head and Neck Cancer, run by IBA Proton Therapy, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ConformalFLASH irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Pennsylvania, Department of Radiation Oncology
Philadelphia, Pennsylvania, 19104
Ching Lai, 267-250-9244, Ching.Lai@pennmedicine.upenn.edu
Karen Tang, 267-299-9618, Karen.Tang1@Pennmedicine.upenn.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- ConformalFLASH irradiation
- Keywords
- Proton Therapy, Ultra-High Dose-Rate
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConformalFLASH irradiationRadiation
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 group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | ConformalFLASH irradiation Receives: Radiation: ConformalFLASH irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 3 months after treatment start
Secondary outcomes (7)
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
Measured: Through treatment completion (within 1 month after last fraction)
Late toxicities
Incidence of late toxicity as assessed by CTCAE version 6.0
Measured: Beyond 3 months after start of treatment and up to 5 years
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
Measured: 3 months and 1 year
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
Measured: 3 months and 1 year
Metastasis-free survival
Time from first treatment to the first occurrence of distant metastatic disease or death from any cause.
Measured: 3 months and 1 year
Overall survival
Time from first treatment to death from any cause
Measured: 3 months and 1 year
Patient-reported quality of life
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start14 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBA Proton Therapy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Alexander Lin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644585
- Sponsor's protocol ID
- IBA-04-UP
- Acronym
- C-FLASH-01
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25680594Heron 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.
PubMed 19464819Lartigau 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.
PubMed 24262821
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT07644585
- Acronym / sponsor ID
- C-FLASH-01 / IBA-04-UP
- Conditions
- Head and Neck Cancer
- Keywords
- Proton Therapy, Ultra-High Dose-Rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- IBA Proton Therapy, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: ConformalFLASH irradiationConformalFLASH irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConformalFLASH irradiationSubjects 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. | Radiation | Treatment Arm |
Primary outcome
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
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
7 secondary outcomes
ConformalFLASH treatment delivery accuracy
Time frame: Through treatment completion (within 1 month after last fraction)
Late toxicities
Time frame: Beyond 3 months after start of treatment and up to 5 years
Local Control
Time frame: 3 months and 1 year
Regional control
Time frame: 3 months and 1 year
Metastasis-free survival
Time frame: 3 months and 1 year
Overall survival
Time frame: 3 months and 1 year
Patient-reported quality of life
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 25680594Vargo 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.
- Results publication: PubMed 19464819Heron 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.
- Results publication: PubMed 24262821Lartigau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Lin, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConformalFLASH irradiation in people with Head and Neck Cancer, run by IBA Proton Therapy, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Le Bail (+32 470 226 032, sophie.lebail@iba-group.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ConformalFLASH treatment delivery feasibility (time frame: Through treatment completion (within 1 month after last fraction)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07644585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.