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Can proton radiation spare tonsil cancer patients from harsh side effects?

NCT ID NCT03829033

Disease control Sponsor: Lund University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether proton therapy causes fewer side effects than standard photon radiation in people with early tonsil cancer. About 100 patients will be randomly assigned to receive one of the two radiation types, both aimed at curing the cancer. Researchers will track acute and late side effects like mouth sores, pain, and swallowing problems to see which approach is gentler.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiotherapy with either photons or protons
What this could lead to
If proton therapy causes fewer side effects, it could become the preferred radiation option for early tonsil cancer, improving patients' quality of life during and after treatment.
What could go wrong
This is a relatively small trial, and results may not show a clear difference between the two radiation types. Proton therapy is also more expensive and less widely available, which could limit its use even if it proves gentler.

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 100 people

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

Started

Jan 2019

Expected to finish

Jan 2028

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: 1. The patient must be at least 18 years old. 2. Histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0 (p16-positive)/N0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. The treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. An excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation. 3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1. 4. The patient must be able to understand the information about the treatment and give a written informed consent. Exclusion Criteria: 1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy 2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years. 3. Two or more synchronous primary cancers in the head and neck region at time of diagnosis 4. Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator 5. Co-existing disease prejudicing survival (expected survival should be \>2 years). 6. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance 7. When dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion.

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Conditions

The condition(s) this trial relates to.

tonsil cancer tonsillar squamous cell carcinoma

As listed by the trial registrant

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

Tonsil cancer

How to take part

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

  1. The places running it

    12 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

  • Gävle Hospital

    RECRUITING

    Gävle, SE-803 24, Sweden

  • Jönköping Hospital

    RECRUITING

    Jönköping, SE-553 05, Sweden

  • Karlstad Hospital

    RECRUITING

    Karlstad, SE-652 30, Sweden

  • Karolinska University Hospital

    RECRUITING

    Stockholm, SE-171 64, Sweden

  • Linköping University Hospital

    RECRUITING

    Linköping, SE-587 50, Sweden

  • Lund University Hospital

    RECRUITING

    Lund, SE-221 85, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, SE-413 46, Sweden

  • Scandion clinic

    RECRUITING

    Uppsala, SE-752 37, Sweden

  • University Hospital

    RECRUITING

    Umeå, SE-907 37, Sweden

  • Uppsala Accademical Hospital

    RECRUITING

    Uppsala, SE-753 09, Sweden

  • Västmanlands Hospital

    RECRUITING

    Västerås, SE-723 35, Sweden

  • Örebro University Hospital

    RECRUITING

    Örebro, SE-703 82, Sweden

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