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Smarter radiation dosing aims to cut side effects for head and neck cancer patients

NCT ID NCT02442375

Disease control Sponsor: Radboud University Medical Center 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new way of giving radiation to people with head and neck cancer. The goal was to lower the radiation dose to healthy neck areas to reduce side effects like trouble eating, while still keeping the cancer from coming back. About 300 patients took part, and the researchers compared the new dosing method to the standard approach.

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

300 people

The number who actually took part.

Started

Jun 2016

Finished

Jul 2024

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 to 80 years

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. Newly diagnosed tumours classified as stage T2-4 N0-2 (TNM 7th edition 2009) located in the larynx, oropharynx or hypopharynx (unknown primary and oral cavity are not eligible) 2. Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour 3. Decision for curative intent external beam radiotherapy with elective treatment of the neck made by a multidisciplinary head-and-neck oncology team. The patient must be expected to complete the treatment. 4. Radiotherapy planned to start within 6 weeks from baseline imaging of tumour assessment 5. No distant metastasis (M0) (TNM 7th edition 2009) 6. WHO performance status 0-2 7. ≥ 18 years of age 8. Written informed consent Exclusion Criteria: 1. Concomitant chemotherapy or EGFR inhibitors for this tumour. 2. Primary tumour of the oral cavity or unknown primary tumour 3. Prior or current anticancer treatment to the head and neck area (e.g. radical attempted or tumour reductive surgery, neo-adjuvant or concomitant chemotherapy, EGFR inhibitors or radiotherapy), except for endoscopic glottic laser micro surgery. 4. Current participation in any other oncologic interventional clinical study for this tumor. 5. Uncontrolled diabetes mellitus. 6. Known or suspected HIV infection. 7. History of previous malignancy within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, basal/squamous cell carcinoma of the skin, and other non-invasive malignancies (e.g. in situ carcinomas).. 8. Any condition (somatic, psychological, familial, sociological or geographical) rendering the patient unable to understand or complete questionnaires.

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Conditions

The condition(s) this trial relates to.

head and neck neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma squamous cell carcinoma

As listed by the trial registrant

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

Carcinoma, squamous cell Head and neck neoplasms

Contacts and locations

Locations

  • MAASTRO clinic, Maastricht

    Maastricht, Netherlands

  • Radboud University Nijmegen Medical Center

    Nijmegen, Netherlands

  • Radiotherapiegroep, Arnhem

    Arnhem, Netherlands

  • University Medical Center Utrecht

    Utrecht, Netherlands

  • VU University Medical Center Amsterdam

    Amsterdam, Netherlands

More trials for these conditions

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