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

NCT05451004 | Recruiting Phase 3 DMC FDA Device

• 2 other identifiers: CCTG-HN11NCI-2022-04496
• Study Type: interventional
• Target: 510
• Locations: 2 countries
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  8 years

Secondary Outcomes (13)

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

  8 years

• Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)

  8 years

• Isolated contralateral neck failure (iCNF)

  8 years

• Overall Survival (OS)

  8 years

• Logo-regional Failure (LRF)

  8 years

Study Arms (2)

Lympathic Mapping with SPECT-CT guided Radiotherapy

EXPERIMENTAL

Other: Lymphatic Mapping with SPECT-CT

Bilateral Neck Radiotherapy

ACTIVE COMPARATOR

Radiation: Ipsilateral and Contralateral Neck

Interventions

Lymphatic Mapping with SPECT-CT OTHER

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

Lympathic Mapping with SPECT-CT guided Radiotherapy

Ipsilateral and Contralateral Neck RADIATION

Radiotherapy

Bilateral Neck Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• NRG Oncology: collaborator
• Alliance for Clinical Trials in Oncology: collaborator
• Eastern Cooperative Oncology Group: collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (36)

City of Hope Corona

Corona, California, 92882, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

SUSPENDED

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

ACTIVE NOT RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607, United States

RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

ACTIVE NOT RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

SUSPENDED

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MD Anderson West Houston

Houston, Texas, 77079, United States

RECRUITING

MD Anderson League City

League City, Texas, 77573, United States

RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

RECRUITING

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

Saint Joseph's Healthcare Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

SUSPENDED

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

SUSPENDED

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 40692081 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• John R de Almeida

  University Health Network, Princess Margaret Hospital, Toronto ON Canada

  STUDY CHAIR

• Ali Hosni

  University Health Network, Princess Margaret Hospital, Toronto ON Canada

  STUDY CHAIR

Central Study Contacts

Wendy Parulekar

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 11, 2022
• Study Start: February 10, 2023
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2031
• Last Updated: April 14, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); CA (10)