New imaging technique may spare throat cancer patients from unnecessary radiation
NCT ID NCT05451004
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 510 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
34 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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BCCA-Vancouver Cancer Centre
RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
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Baptist MD Anderson Cancer Center
ACTIVE_NOT_RECRUITINGJacksonville, Florida, 32207, United States
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CHUM - Centre Hospitalier de l'Universite de Montreal
RECRUITINGMontreal, Quebec, H2X 3E4, Canada
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CancerCare Manitoba
RECRUITINGWinnipeg, Manitoba, R3E 0V9, Canada
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Central Vermont Medical Center/National Life Cancer Treatment
RECRUITINGBerlin Corners, Vermont, 05602, United States
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Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
RECRUITINGSherbrooke, Quebec, J1H 5N4, Canada
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City of Hope Comprehensive Cancer Center
RECRUITINGDuarte, California, 91010, United States
Contact Email: •••••@•••••
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City of Hope Corona
RECRUITINGCorona, California, 92882, United States
Contact Email: •••••@•••••
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City of Hope at Irvine Lennar
SUSPENDEDIrvine, California, 92618, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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Health Sciences North
RECRUITINGGreater Sudbury, Ontario, P3E 5J1, Canada
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Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
Contact Email: •••••@•••••
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Jewish General Hospital
ACTIVE_NOT_RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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MU Health - University Hospital/Ellis Fischel Cancer Center
RECRUITINGColumbia, Missouri, 65212, United States
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MetroHealth Medical Center
RECRUITINGCleveland, Ohio, 44109, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
Contact Email: •••••@•••••
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Moffitt Cancer Center - McKinley Campus
RECRUITINGTampa, Florida, 33612, United States
Contact Email: •••••@•••••
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Moffitt Cancer Center-International Plaza
RECRUITINGTampa, Florida, 33607, United States
Contact Email: •••••@•••••
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Northwestern Medicine Cancer Center Warrenville
ACTIVE_NOT_RECRUITINGWarrenville, Illinois, 60555, United States
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Northwestern University
ACTIVE_NOT_RECRUITINGChicago, Illinois, 60611, United States
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Odette Cancer Centre- Sunnybrook Health Sciences Centre
SUSPENDEDToronto, Ontario, M4N 3M5, Canada
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Providence Portland Medical Center
RECRUITINGPortland, Oregon, 97213, United States
Contact Email: •••••@•••••
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Saint Joseph's Healthcare Charlton Campus
SUSPENDEDHamilton, Ontario, L8N 4A6, Canada
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The James Graham Brown Cancer Center at University of Louisville
SUSPENDEDLouisville, Kentucky, 40202, United States
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UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITINGCoral Gables, Florida, 33146, United States
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UNC Lineberger Comprehensive Cancer Center
RECRUITINGChapel Hill, North Carolina, 27599, United States
Contact Email: •••••@•••••
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UT MD Anderson - League City
RECRUITINGLeague City, Texas, 77573, United States
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UT MD Anderson - Sugar Land
RECRUITINGSugar Land, Texas, 77478, United States
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UT MD Anderson - The Woodlands
RECRUITINGConroe, Texas, 77384, United States
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UT MD Anderson - West Houston
RECRUITINGHouston, Texas, 77079, United States
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UT MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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University Health Network-Princess Margaret Hospital
RECRUITINGToronto, Ontario, M5G 2M9, Canada
Contact Email: •••••@•••••
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University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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University of Michigan - Brighton Center for Specialty Care
RECRUITINGBrighton, Michigan, 48116, United States
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University of Michigan Rogel Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
Contact Email: •••••@•••••
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University of Vermont Medical Center
RECRUITINGBurlington, Vermont, 05401, United States
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University of Vermont and State Agricultural College
RECRUITINGBurlington, Vermont, 05405, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can steroids, a migraine drug, or tongue exercises save nerves after throat cancer treatment?
- New drug combo targets HPV-Driven cancers in phase II trial
- New sedative could speed recovery for ventilator patients
- Can light be the new shield against radiation mouth sores?
- Could a common numbing drug help fight throat cancer?
- Could less radiation be better? new trial spares healthy neck tissue