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Can less radiation be safer for throat cancer?

NCT ID NCT04609280

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether giving radiation to a smaller area of the neck can prevent throat cancer from returning while reducing side effects. People with p16-positive oropharynx cancer (a type linked to HPV) who are getting radiation therapy may be eligible. The goal is to see if shrinking the radiation target on one side of the neck is just as effective but gentler on swallowing and saliva.

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 (IMRT/VMAT or proton beam therapy) with reduced treatment volumes in the neck
What this could lead to
If successful, this approach could reduce side effects like dry mouth and swallowing problems without increasing the risk of cancer returning in the neck.
What could go wrong
This is a phase II trial with a modest number of participants, so results may not be definitive. There is a risk that reducing radiation could allow cancer to recur in untreated areas.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

52 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Dec 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.

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. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil or base of tongue)? Note: Cytologic diagnosis from a cervical lymph node (from a paraffin block, not from smears) is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage). 2. Does the patient require elective contralateral radiotherapy in the definitive or adjuvant setting (i.e. base of tongue primary or tonsil with base of tongue invasion, soft palate invasion, or medialized as defined by \> 1/3 of the distance from the tonsil to the midline of the soft palate? 3. Does the patient have clinical stage T1-4, N0, N1 or N3, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT)? 4. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration? 5. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration? 6. Is the patient ≥ 18 years of age? 7. For women of childbearing potential, was a serum pregnancy test completed within 2 weeks of initiation or radiotherapy? 8. If yes, was the serum pregnancy test negative? 9. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment. 10. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review? Exclusion Criteria: 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx? 2. Does the patient have a carcinoma of the neck of unknown primary origin? 3. Does the patient have distant metastasis? 4. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years? 5. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)? 6. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields? 7. Did the patient have prior surgery of the head and neck excluding superficial removal of cutaneous skin malignancies? 8. Is the patient homeless? 9. Does the patient have an active drug or alcohol dependency? 10. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)? 11. Radiographic evidence of contralateral nodal disease as described below. 1) Max standardized uptake value (SUV) greater than 3.0, or 2) Short-axis diameter is \> 1.5 cm for level II nodes, \> 0.8 cm for retropharyngeal node, or \> 1.0 cm for level III, IV, or V, or 3) Central necrosis or heterogeneous enhancement

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms oropharynx cancer oropharynx 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.

Contacts and locations

Locations

  • Baltimore Washington Medical Center

    Glen Burnie, Maryland, 21061, United States

  • Central Maryland Radiation Oncology

    Columbia, Maryland, 21044, United States

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201, United States

  • UMMC

    Baltimore, Maryland, 21201, United States

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • Upper Chesapeake Health

    Bel Air, Maryland, 21014, United States

More trials for these conditions

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