Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New surgical trick may prevent dangerous leaks after throat cancer surgery

NCT ID NCT06287034

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at whether using a piece of the patient's own tissue (a flap) to reinforce the closure after removing the voice box can reduce the risk of a throat leak (fistula). About 102 people whose throat cancer has returned after radiation or chemoradiation will be randomly assigned to standard closure or closure with a flap. The goal is to see which approach leads to fewer leaks and better quality of life.

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.

Participants

About 102 people

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

Started

Mar 2023

Expected to finish

Sep 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.

Who is studied

Patients suffering from recurrence/persistence of laryngeal SCC following exclusive RT treatment or concomitant RT/ChT without extension to the pharynx (rcT1/T2/T3 selected rcT4a N0/N+) who will have to undergo STL and who will meet the following criteria. Patients undergoing extensive laryngectomies or with disease with even partial involvement of the pharyngeal mucosa (pyriform sinus, posterior wall of the pharynx) will not be included.

Ages

18 years and older

Sex

Anyone

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: * Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment: 1. pre (ChT-)RT staging: cT1/T2/T3 N0/N+; 2. pre STL staging: rcT1/cT2/ Selected cT3 cT4a (extension to thyroid cartilage and/or prelaryngeal tissues) N0/N+ (clinically and radiologically). * Indication for STL surgery (no pharyngeal mucosal resection); * Functional total laryngectomies after radical (chemo-)radiotherapy treatment; * Age \> 18 years; * Signature of informed consent and ability to complete in-office questionnaires. Exclusion Criteria: * STL extended to the pharynx and/or total pharyngeal laryngectomies; * Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension; * Previous open organ preservation surgery (OPHL).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Laryngeal carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

laryngeal carcinoma laryngeal neoplasm laryngeal squamous cell carcinoma

As listed by the trial registrant

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

Larynx carcinoma

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

  • "Regina Elena" National Cancer Institute

    RECRUITING

    Rome, Rome, 00144, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.