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New imaging technique may spare throat cancer patients from unnecessary radiation

NCT ID NCT05451004

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether using a special scan (SPECT-CT) to guide radiation to only one side of the neck works as well as standard radiation to both sides for people with oropharyngeal cancer. The study includes 510 participants with early-stage cancer on one side of the throat. The goal is to see if this targeted approach can reduce side effects like swallowing difficulties and dry mouth without increasing the risk of cancer returning.

What this could mean

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

Active substance
Radiotherapy
What this could lead to
If successful, this approach could reduce side effects like swallowing problems and dry mouth while maintaining cancer control.
What could go wrong
This is a large phase 3 trial, but it's still possible that the guided treatment leads to higher cancer recurrence. Results are not yet available.

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 510 people

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

Started

Feb 2023

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline. * HPV positive or negative (by p16 immunohistochemistry). * Clinical stage T1-3 M0 (UICC/AJCC TNM 8th Edition). Nodal involvement may include no nodes or single or multiple ipsilateral lymph nodes (largest ≤6cm in maximum diameter) * Radiological investigations within 8 weeks of registration: * CT or MRI of the neck (with head imaging as indicated); * PET-CT scan * Chest CT scan * Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded). * Intent to deliver concurrent chemotherapy or not must be known at the time of randomization. As this is a pragmatic trial, even patients who are not candidates for systemic therapy will be eligible for participation. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Willing to complete the quality of life and/or health utility questionnaire, if sufficiently fluent in available language(s). * Informed consent prior to registration * Accessible for treatment and follow-up. * Commencement of definitive RT within 28 days (+ 14 days) of randomization. * Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patient must consent to provision of, and investigator(s) must confirm location and commitment to obtain a representation of formalin fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays Exclusion Criteria: * T1-T2 cancers isolated to the tonsil fossa (i.e. without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node \< 3 cm without extranodal extension. * Tonsil or tongue base primary cancer who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease * Previous head and neck cancer or multiple synchronous primary head and neck cancers * Previous induction or neo-adjuvant chemotherapy. * Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are eligible * Radiotracer allergy * Severe, active co-morbidity including any of the following: * Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration * Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of registration * Acute myocardial infarction within 30 days of study registration * Diseases precluding RT (e.g. scleroderma)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    34 sites in 2 countries. 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

  • BCCA-Vancouver Cancer Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Baptist MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32207, United States

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Central Vermont Medical Center/National Life Cancer Treatment

    RECRUITING

    Berlin Corners, Vermont, 05602, United States

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • City of Hope Corona

    RECRUITING

    Corona, California, 92882, United States

    Contact Email: •••••@•••••

  • City of Hope at Irvine Lennar

    SUSPENDED

    Irvine, California, 92618, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Health Sciences North

    RECRUITING

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Jewish General Hospital

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    RECRUITING

    Columbia, Missouri, 65212, United States

  • MetroHealth Medical Center

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center - McKinley Campus

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center-International Plaza

    RECRUITING

    Tampa, Florida, 33607, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Cancer Center Warrenville

    ACTIVE_NOT_RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern University

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    SUSPENDED

    Toronto, Ontario, M4N 3M5, Canada

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Saint Joseph's Healthcare Charlton Campus

    SUSPENDED

    Hamilton, Ontario, L8N 4A6, Canada

  • The James Graham Brown Cancer Center at University of Louisville

    SUSPENDED

    Louisville, Kentucky, 40202, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • UT MD Anderson - League City

    RECRUITING

    League City, Texas, 77573, United States

  • UT MD Anderson - Sugar Land

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • UT MD Anderson - The Woodlands

    RECRUITING

    Conroe, Texas, 77384, United States

  • UT MD Anderson - West Houston

    RECRUITING

    Houston, Texas, 77079, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University Health Network-Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

    Contact Email: •••••@•••••

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan - Brighton Center for Specialty Care

    RECRUITING

    Brighton, Michigan, 48116, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Vermont and State Agricultural College

    RECRUITING

    Burlington, Vermont, 05405, United States

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