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NCT05451004PHASE3Recruiting

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

Canadian Cancer Trials Group

Start Date

2/10/2023

Completion Date

8/30/2031

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?

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

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

OTHER

Lymphatic Mapping with SPECT-CT

RADIATION

Ipsilateral and Contralateral Neck

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Conditions

Oropharyngeal Cancer

Locations

City of Hope Corona

Corona, California 92882

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

City of Hope at Irvine Lennar

Irvine, California 92618

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida 33146

United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida 32207

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida 33136

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida 33612

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Northwestern University

Chicago, Illinois 60611

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois 60555

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky 40202

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan 48109

United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan 48116

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri 65212

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27599

United States

MetroHealth Medical Center

Cleveland, Ohio 44109

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

UT MD Anderson - The Woodlands

Conroe, Texas 77384

United States

UT MD Anderson Cancer Center

Houston, Texas 77030

United States

UT MD Anderson - West Houston

Houston, Texas 77079

United States

UT MD Anderson - League City

League City, Texas 77573

United States

UT MD Anderson - Sugar Land

Sugar Land, Texas 77478

United States

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont 05602

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont 05405

United States

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia V5Z 4E6

Canada

CancerCare Manitoba

Winnipeg, Manitoba R3E 0V9

Canada

Health Sciences North

Greater Sudbury, Ontario P3E 5J1

Canada

Saint Joseph's Healthcare Charlton Campus

Hamilton, Ontario L8N 4A6

Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario L8V 5C2

Canada

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario M5G 2M9

Canada

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 3E4

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec J1H 5N4

Canada