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Smarter radiation for head & neck cancer: Biopsy-Guided treatment may spare patients from dry mouth

NCT ID NCT05333523

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether using a sentinel lymph node biopsy to guide radiation can safely reduce the amount of neck radiation in people with certain head and neck cancers. The goal is to lower long-term side effects like severe dry mouth while still controlling the cancer. About 242 adults with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx will be randomly assigned to standard neck radiation or a personalized approach based on biopsy results.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 242 people

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

Started

Dec 2023

Expected to finish

Dec 2029

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: * Adult patients (≥18 years) with newly diagnosed cT1-4N0-2bM0 squamous cell carcinoma of the oropharynx (HPV-), larynx or hypopharynx, or cT1-4N0-1M0 oropharynx (HPV+) (AJCC TNM 8) * Histopathological diagnosis of squamous cell carcinoma. * Adequate staging of the neck including CT or MRI, and 18F-FDG-PET demonstrating no contralateral lymph node metastases. * Recommendation for curative intent external beam (chemo)radiotherapy made by a multidisciplinary head and neck oncology team (in case of chemoradiotherapy, only patients receiving concomitant platinum-based regimen are eligible). * Bilateral ENI is indicated according to Dutch consensus guidelines (LPHHRT) (see Appendix 13.1). * Procedures for SLNB (i.e. tumor accessible for tracer injection, imaging and surgery under general anesthesia) are deemed feasible by the head and neck surgeon. Exclusion Criteria: * Recurrent disease or previous anticancer treatment to the head and neck area (e.g. radical attempt or tumor reductive surgery, neck dissection, neo-adjuvant chemotherapy or radiotherapy) except for endoscopic glottic laser micro surgery. * Well lateralized oropharyngeal cancers and early stage laryngeal cancers requiring no or unilateral ENI according to Dutch consensus guidelines (LPHHRT) * Patients receiving concomitant non-platinum-based systemic agents (e.g. cetuximab). * Patients that qualify for proton therapy and want to be treated accordingly. * Compromised airway or tracheostomy. * Any active invasive malignancy within the last 3 years except for early stage basal/squamous cell carcinoma of the skin and incidental finding of stage T1N0M0 prostate cancer. * Any somatic, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma oropharynx squamous cell carcinoma squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Hypopharynx squamous cell carcinoma Laryngeal squamous cell carcinoma Oropharyngeal squamous cell carcinoma

How to take part

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

  1. The places running it

    9 sites. 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

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

  • MAASTRO Clinic / Maastricht University Medical Center

    RECRUITING

    Maastricht, Netherlands

  • Medisch Spectrum Twente (MST)

    NOT_YET_RECRUITING

    Enschede, Netherlands

  • Radboud University Nijmegen Medical Center

    RECRUITING

    Nijmegen, Netherlands

  • Radiotherapiegroep / Rijnstate Ziekenhuis

    NOT_YET_RECRUITING

    Arnhem, Netherlands

  • The Netherlands Cancer Institute

    RECRUITING

    Amsterdam, Netherlands

  • University Medical Center Groningen

    RECRUITING

    Groningen, Netherlands

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, Netherlands

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