RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2023-02-10

Study Completion:2031-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05451004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Wendy Parulekar

CONTACT

613-533-6430

wparulekar@ctg.queensu.ca

Principal Investigator

John R de Almeida

STUDY_CHAIR

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Ali Hosni

STUDY_CHAIR

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Study Locations (Sites)

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 Comprehensive 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

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

MD Anderson in The Woodlands

Conroe, Texas, 77384

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

MD Anderson West Houston

Houston, Texas, 77079

United States

MD Anderson League City

League City, Texas, 77573

United States

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

United States

Collaborators and Investigators

Sponsor: Canadian Cancer Trials Group

John R de Almeida, STUDY_CHAIR, University Health Network, Princess Margaret Hospital, Toronto ON Canada
Ali Hosni, STUDY_CHAIR, University Health Network, Princess Margaret Hospital, Toronto ON Canada

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10

Study Completion Date2031-08-30

Study Record Updates

Study Start Date2023-02-10

Study Completion Date2031-08-30

Terms related to this study

Additional Relevant MeSH Terms

Oropharyngeal Cancer