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Could less radiation be enough for HPV-Positive throat cancer?

NCT ID NCT03396718

Disease control Sponsor: Technische Universität Dresden 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a lower dose of radiation after surgery can safely treat HPV-positive head and neck cancer while reducing long-term side effects. About 304 participants will receive either standard or reduced radiation, with or without chemotherapy. The goal is to see if the lower dose still prevents cancer from coming back.

What this could mean

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

Active substance
radiation therapy (reduced dose)
What this could lead to
If successful, this could show that a lower radiation dose is safe and effective for HPV-positive head & neck cancer, reducing long-term side effects without compromising disease control.
What could go wrong
This is an early-phase study, so the reduced dose might not control the cancer as well as standard treatment. Long-term results are not yet known, and side effects could still occur.

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 304 people

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

Started

Nov 2018

Expected to finish

Nov 2032

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: * Condition after surgical removal of a squamous cell carcinoma of the oropharynx and adequate lymph node dissection * Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary tumor board * Good general state (ECOG performance status 0 or 1) * Adequate compliance to ensure closely follow-up * Patient's consent and written consent * Neck dissection of at least the tumor bearing side Additional Inclusion Criteria Arm intermediate risk (at least one of the criteria must be fulfilled): * pT3 and R0 and / or * histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular extension of the lymph node metastasis Additional Inclusion Criteria Arm high risk (at least one of the criteria must be fulfilled): * residual tumor (R1 status) and / or * pathologic stage T4 (pT4) status and / or * more than 3 infected lymph nodes and / or * extracapsular extension of at least one lymph node metastasis Exclusion Criteria: * Patients with a cumulative nicotine abuse \> 30 packyears. These patients are not included in the intervention arms, but are always included in the observation arms (regardless of HPV status). * radiologically presumed or histologically confirmed distant metastasis * R2 resection or macroscopically visible residual tumor after surgery * no neck dissection * interval between last operation and planned irradiation start \> 7 weeks * contraindication against a guideline-appropriate adjuvant radiation or radiochemotherapy according to the clinical risk constellation * tumor disease in the last five years before the beginning of the study (except basaliomas of the skin, in-situ carcinoma of the cervix uteri or breast, or tumors with similar prognosis which are considered to be very likely to be cured) * malignant tumor disease in the head and neck region, regardless of interval and prognosis * Pre-irradiation with risk of dose overlap * participation in another clinical trial if further experimental therapy is necessary or the treatments/ protocols are mutually exclusive (e.g. altered chemotherapy, additional consolidation chemotherapy). Allowed is the additional participation in observation studies or supportive therapy studies. * diseases or conditions which do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial * pregnant or lactating women * evidence that the participant is not expected to comply with the study protocol (e.g. lack of cooperation) * missing written consent

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma human papillomavirus-related squamous cell carcinoma oropharynx cancer Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Head and neck squamous cell carcinoma

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Charité - Universitätsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • LMU Munich University Hospital

    RECRUITING

    München, 81377, Germany

  • TUM University Hospital

    RECRUITING

    München, 81675, Germany

  • University Clinic Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • University Clinic Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • University Clinic Frankfurt

    RECRUITING

    Frankfurt am Main, 60590, Germany

  • University Clinic Freiburg

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • University Clinic Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • University Clinic Regensburg

    RECRUITING

    Regensburg, 93053, Germany

  • University Clinic Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72016, Germany

    Contact Email: •••••@•••••

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