Comparing Lymphatic Mapping with SPECT-CT with Ipsilateral and Contralateral Neck for oropharyngeal cancer
Official title: SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial
- Phase 3
- 2 groups
- Sites in Vancouver, Winnipeg and 5 more cities
- Recruiting
Interventions
- Other intervention
Lymphatic Mapping with SPECT-CT
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy
- Radiation therapy
Ipsilateral and Contralateral Neck
Radiotherapy
Canadian Sites (10)
7 of 10 recruiting
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba
- Recruiting
Health Sciences North
Greater Sudbury, Ontario
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario
- Recruiting
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec
- Paused
Saint Joseph's Healthcare Charlton Campus
Hamilton, Ontario
- Paused
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario
- Not currently recruiting
Jewish General Hospital
Montreal, Quebec
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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)
- +Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
- +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).
- +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).
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to registration
- +Accessible for treatment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
- +Commencement of definitive RT within 28 days (+ 14 days) of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →(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
- +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.
Exclusion
- −Radiotracer allergy
- −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
- −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)
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Lymphatic Mapping with SPECT-CT.
Registry label: A: Lympathic Mapping with SPECT-CT guided Radiotherapy
Group B, the comparison group, receives Ipsilateral and Contralateral Neck.
Registry label: B: Bilateral Neck Radiotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 510 people.
The study is currently expected to finish around August 2031.
The main measurement is taken over: 8 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Disease-free Survival — measured over 8 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05451004 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Lymphatic Mapping with SPECT-CTOther
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Ipsilateral and Contralateral NeckRadiation
Radiotherapy
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 8 years.
The study as a whole is currently expected to finish around 2031-08-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 510 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?
Other Sites (3)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.