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MRI-Guided radiation boost shows promise in head and neck cancer trial

NCT ID NCT06880289

Disease control Sponsor: Regina Elena Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether giving an extra dose of radiation to oxygen-poor (hypoxic) areas of head and neck tumors can improve treatment response. About 91 adults with advanced squamous cell cancer of the throat or voice box will receive standard chemo-radiation with or without the MRI-guided boost. The goal is to see if the boost leads to complete tumor disappearance.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 91 people

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

Started

Sep 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; * AJCC stage III or IV (cT2-4 N0-3 M0); * specific informed consent. Exclusion Criteria: * Documented allergy to radiological contrast media or inability to receive contrast media due to concomitant pathology (e.g. renal); * inability to receive radiotherapy (e.g. previous radiotherapy in the same region) and/or chemotherapy (inadequate bone marrow and/or liver and/or renal function); * incomplete acquisition of MRI images; * performance status 2 or more according to Zubrod; * Previous invasive neoplasm (except skin cancer), except for neoplasms controlled for at least three years; non-invasive tumors (e.g. carcinoma in situ of the breast) are admitted even if diagnosed and treated in a period less than 3 years prior; patients with simultaneous or bilateral primary tumors are excluded; * alcohol or drug abuse; * legal incapacity or limited legal capacity; * concomitant treatment with investigational drugs or participation in another clinical trial with use of investigational drugs within 30 days prior to screening for the study; * documented hypersensitivity to study drugs or any of their excipients; * pregnancy and/or breastfeeding.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma oropharynx squamous cell carcinoma

As listed by the trial registrant

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

Squamous cell tumors of the head and neck

Contacts and locations

Locations

  • "Regina Elena" National Cancer Institute

    Rome, Rome, 00144, Italy

  • IRCSS Regina Elena

    Roma, Roma, 00144, Italy

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