AzTrials
AzTrials

Oropharyngeal CancerPhase 3SELECTNCT05451004

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

A Phase 3 study testing Lymphatic Mapping with SPECT-CT and Ipsilateral and Contralateral Neck in people with Oropharyngeal Cancer, run by Canadian Cancer Trials Group at 38 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Cancer
What is being tested?
Lymphatic Mapping with SPECT-CT and Ipsilateral and Contralateral Neck
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
38 sitesin 2 countries
Study dates
10 Feb 2023to 30 Aug 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

38 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Wendy Parulekar contact

613-533-6430

wparulekar@ctg.queensu.ca

38 sites in 2 countries

United States28 sites, 23 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    David W. Forner

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    James E. Bates

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Mark H. Sueyoshi

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    David W. Forner

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Mark H. Sueyoshi

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Mark H. Sueyoshi

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Colette Shen

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Active, not recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Site Public Contact, 216-778-7559, ababal@metrohealth.org

    Akash N. Naik

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Patrick Tassone

    Recruiting

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Anna Lee

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Gregory J. Kubicek

    Recruiting

  • City of Hope Corona

    Corona, California, 92882

    Site Public Contact, 626-256-4673, becomingapatient@coh.org

    Krupal B. Patel

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Samantha H. Tam

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Krupal B. Patel

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Anna Lee

    Recruiting

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Anna Lee

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Suspended

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

    Active, not recruiting

  • UT MD Anderson - League City

    League City, Texas, 77573

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Anna Lee

    Recruiting

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

    Suspended

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

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Gregory J. Kubicek

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Charles W. Drescher

    Recruiting

  • UT MD Anderson - Sugar Land

    Sugar Land, Texas, 77478

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Anna Lee

    Recruiting

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Deepa Danan

    Recruiting

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Deepa Danan

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Deepa Danan

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Active, not recruiting

Other trials in United States

Canada10 sites, 7 recruiting

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

    Site Public Contact, 706-522-6237 ext. 2401, japaquette@hrsrh.on.ca

    Mirko Manojlovic Kolarski

    Recruiting

  • Saint Joseph's Healthcare Charlton Campus

    Hamilton, Ontario, L8N 4A6

    Suspended

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Site Public Contact, 905-387-9495

    Nhu Tram A. Nguyen

    Recruiting

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Site Public Contact, 514-890-8000 ext. 12725, info.cr.chum@ssss.gouv.qc.ca

    Apostolos Christopoulos

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Active, not recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

    Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca

    Isabelle Gauthier

    Recruiting

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Suspended

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca

    Ali Hosni

    Recruiting

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

    Site Public Contact, 888-939-3333

    Eric Tran

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca

    Carlton Johnny John Pandian

    Recruiting

Other trials in Canada

About this study

Official title: SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled 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?

Read the detailed description

This study is being conducted in order to find out if this approach is as good as the usual approach in controlling the cancer and has fewer side effects and better quality of life. The usual approach for patients who are not in a study is treatment which includes radiotherapy to the tumour and to both sides of the neck to decrease the risk of spread or recurrence of the cancer

Being tested
Lymphatic Mapping with SPECT-CT, Ipsilateral and Contralateral Neck
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lymphatic Mapping with SPECT-CTOther

    Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy

  • Ipsilateral and Contralateral NeckRadiation

    Radiotherapy

Study groups in NCT05451004
Study groupRoleWhat they receive
Lympathic Mapping with SPECT-CT guided RadiotherapyExperimentalNot described
Receives: Other: Lymphatic Mapping with SPECT-CT
Bilateral Neck RadiotherapyActive comparatorNot described
Receives: Radiation: Ipsilateral and Contralateral Neck

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    Measured: 8 years

Secondary outcomes (13)

  1. Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)

    Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing).

    Measured: 8 years

  2. Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)

    Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT

    Measured: 8 years

  3. Isolated contralateral neck failure (iCNF)

    Measured: 8 years

  4. Overall Survival (OS)

    Measured: 8 years

  5. Logo-regional Failure (LRF)

    Measured: 8 years

  6. Distant Metastases (DM)

    Measured: 8 years

  7. Incidence and Severity of Radiation-related Toxicities

    Measured: 8 years

  8. Patient-Reported Toxicities using PRO CTCAE

    Measured: 8 years

  9. Gastrostomy Tube Usage

    Measured: 8 years

  10. Resource Utilization

    Measured: 8 years

  11. Lost Productivity

    Healthcare system and societal resources will be quantified over the course of the trial to generate utilization information by patient in each study arm. We will generate an average cost per study subject by treatment arm for an overall mean cost per study arm

    Measured: 8 years

  12. Financial Toxicity [Financial Index of Toxicity (FIT)]

    Measured: 8 years

  13. Health Utilities using EQ-5D

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start10 Feb 2023
  3. Primary completion30 Aug 2030 (estimated)
  4. Study completion30 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451004
Sponsor's protocol ID
CCTG-HN11
Other IDs
CCTG-HN11, NCI-2022-04496
Acronym
SELECT
Status last verified
Jun 2026
First submitted
30 Jun 2022
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gau M, Alfaraj FA, Huang SH, O'Sullivan B, Su J, Xu W, Hamilton SN, Maletta A, Salman O, McInerney M, Javed A, Sanz-Garcia E, Bratman S, Hahn E, Hope A, Kim JJ, Malik N, McPartlin A, Tsai CJ, Waldron J, Yao CMKL, de Almeida JR, Hosni A. Unilateral vs bilateral neck irradiation: The importance of careful patient selection in tailoring radiation therapy for lateralized palatine-tonsil and non-palatine-tonsil oropharyngeal carcinoma. Radiother Oncol. 2025 Sep;210:111049. doi: 10.1016/j.radonc.2025.111049. Epub 2025 Jul 19.

    PubMed 40692081

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lymphatic Mapping with SPECT-CT and Ipsilateral and Contralateral Neck in people with Oropharyngeal Cancer, run by Canadian Cancer Trials Group at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wendy Parulekar (613-533-6430, wparulekar@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in