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FLASH therapy: a flash of hope for head and neck cancer retreatment?

NCT ID NCT07644585

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This early study tests a new type of radiation therapy called ConformalFLASH, which delivers radiation at an ultra-high speed. It is for 10 adults with head and neck cancer who need a second round of radiation but cannot have surgery. The goal is to see if this fast treatment is possible and safe, with the hope of reducing side effects compared to standard radiation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. Patients ≥ 18 years old 3. Patients ineligible for or decline upfront surgical resection 4. Histologically confirmed diagnosis of carcinoma of the head and neck 5. Prior receipt of at least 45 GyRBE radiotherapy to the head and neck 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record 7. Life expectancy of more than 12 weeks 8. Ability to understand and the willingness to provide written informed consent and to follow the study procedures Exclusion Criteria: 1. Receipt of prior head and neck radiotherapy within the prior 6 months 2. Surgical resection of the current disease in the head and neck 3. More than 3 areas of disease requiring reirradiation 4. Disease focus exceeding 6.5 cm in greatest dimension 5. Presence of distant metastatic disease 6. Involvement of any of the following structures: skin, carotid artery, or mandible 7. Receipt of concurrent chemotherapy during radiotherapy 8. Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements 9. Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT 10. Pregnant and/or breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Pennsylvania, Department of Radiation Oncology

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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