Recruiting

Phase 3

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

Sponsor:

Canadian Cancer Trials Group

Code:

NCT05451004

Conditions

Oropharyngeal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lymphatic Mapping with SPECT-CT

Ipsilateral and Contralateral Neck

Study Details

Brief 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 when radiotherapy is given to both sides of the neck?

Conditions

Oropharyngeal Cancer

Study ID

NCT05451004

Start date

Feb 10, 2023

Status verified date

Jun, 2026

Completion date

Aug 30, 2031

Anticipated

Primary completion date

Aug 30, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lympathic Mapping with SPECT-CT guided Radiotherapy

active comparator: Bilateral Neck Radiotherapy

Interventions

Lymphatic Mapping with SPECT-CT

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

Ipsilateral and Contralateral Neck

Radiotherapy

Primary outcome measure

Disease-free Survival [ Time Frame: 8 years ]

Central Contacts and Locations

Central contacts

Wendy Parulekar

613-533-6430 wparulekar@ctg.queensu.ca

Locations

City of Hope Corona

Recruiting

Corona, California, United States, 92882

Contacts

Site Public Contact

626-256-4673 becomingapatient@coh.org

Principal Investigator:

Krupal B. Patel

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673 becomingapatient@coh.org

Principal Investigator:

Krupal B. Patel

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Gregory J. Kubicek

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Gregory J. Kubicek

Moffitt Cancer Center-International Plaza

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Public Contact

800-679-0775 ClinicalTrials@moffitt.org

Principal Investigator:

Deepa Danan

Moffitt Cancer Center - McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Public Contact

800-679-0775 ClinicalTrials@moffitt.org

Principal Investigator:

Deepa Danan

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Public Contact

800-679-0775 ClinicalTrials@moffitt.org

Principal Investigator:

Deepa Danan

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

James E. Bates

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125 CancerAnswerLine@med.umich.edu

Principal Investigator:

David W. Forner

University of Michigan - Brighton Center for Specialty Care

Recruiting

Brighton, Michigan, United States, 48116

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

David W. Forner

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721 CTOResearch@hfhs.org

Principal Investigator:

Samantha H. Tam

MU Health - University Hospital/Ellis Fischel Cancer Center

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Site Public Contact

573-882-7440

Principal Investigator:

Patrick Tassone

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683 cancerclinicaltrials@med.unc.edu

Principal Investigator:

Colette Shen

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Site Public Contact

216-778-7559 ababal@metrohealth.org

Principal Investigator:

Akash N. Naik

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614 CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

UT MD Anderson - The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Site Public Contact

866-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Anna Lee

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

866-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Anna Lee

UT MD Anderson - West Houston

Recruiting

Houston, Texas, United States, 77079

Contacts

Site Public Contact

877-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Anna Lee

UT MD Anderson - League City

Recruiting

League City, Texas, United States, 77573

Contacts

Site Public Contact

877-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Anna Lee

UT MD Anderson - Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Site Public Contact

877-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Anna Lee

Central Vermont Medical Center/National Life Cancer Treatment

Recruiting

Berlin Corners, Vermont, United States, 05602

Contacts

Site Public Contact

802-225-5400

Principal Investigator:

Mark H. Sueyoshi

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Site Public Contact

802-656-4101 rpo@uvm.edu

Principal Investigator:

Mark H. Sueyoshi

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990 rpo@uvm.edu

Principal Investigator:

Mark H. Sueyoshi

BCCA-Vancouver Cancer Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Site Public Contact

888-939-3333

Principal Investigator:

Eric Tran

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Site Public Contact

866-561-1026 ctu_web@cancercare.mb.ca

Principal Investigator:

Carlton Johnny John Pandian

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Site Public Contact

706-522-6237 japaquette@hrsrh.on.ca

Principal Investigator:

Mirko Manojlovic Kolarski

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Site Public Contact

905-387-9495

Principal Investigator:

Nhu Tram A. Nguyen

University Health Network-Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Site Public Contact

416-946-4501 clinical.trials@uhn.on.ca

Principal Investigator:

Ali Hosni

CHUM - Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Site Public Contact

514-890-8000 info.cr.chum@ssss.gouv.qc.ca

Principal Investigator:

Apostolos Christopoulos

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Site Public Contact

819-820-6480 crcinformation.chus@ssss.gouv.qc.ca

Principal Investigator:

Isabelle Gauthier

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Jul 14, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-07-14.