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SPECT-CT Guided Radiotherapy for Oropharyngeal Cancer

This study is looking at a new way to treat lateralized oropharyngeal cancer (cancer on one side of the throat). It compares two approaches for radiotherapy (radiation treatment) to the neck. One approach uses a special imaging scan called lymphatic mapping with SPECT-CT (Single Photon Emission Computed Tomography) to guide radiotherapy to the affected side and the other side of the neck. The other approach is the usual treatment, which gives radiotherapy to both sides of the neck. The study wants to see if the SPECT-CT guided treatment is just as good at preventing the cancer from spreading or coming back, but with fewer side effects and a better quality of life. You may be able to join if you are 18 or older, have a confirmed diagnosis of lateralized oropharyngeal cancer that hasn't spread to other parts of the body (T1-3 M0), and your cancer is HPV positive or negative. The study aims to enroll 510 participants and will measure how long people live without the disease for 8 years.

Study design
This interventional study plans to enroll 510 participants to compare two different radiotherapy approaches for oropharyngeal cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease-free survival for 8 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05451004

SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Canadian Cancer Trials Group
~510 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Lymphatic Mapping with SPECT-CTIpsilateral and Contralateral Neck

At a glance

Recruiting sites
30 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free Survival
Measured over 8 years

Conditions

Oropharyngeal Cancer

Explore related trials

Oropharyngeal Carcinoma

NCT05451004

Where you'd take part

This study runs at 38 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, Canadastudy coordinator listed

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, Canadastudy coordinator listed

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermontstudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, Canadastudy coordinator listed

    Recruiting

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, Canadastudy coordinator listed

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • City of Hope Corona

    Corona, Californiastudy coordinator listed

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John R de Almeida · STUDY_CHAIR · University Health Network, Princess Margaret Hospital, Toronto ON Canada
  • Ali Hosni · STUDY_CHAIR · University Health Network, Princess Margaret Hospital, Toronto ON Canada

Who to contact

Wendy Parulekar
[email protected]
613-533-6430
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Disease-free Survival8 years