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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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?

Who May Be Eligible (Plain English)

Who May Qualify: - 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). - willing to sign a consent form 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 Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

OTHER

Lymphatic Mapping with SPECT-CT

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

RADIATION

Ipsilateral and Contralateral Neck

Radiotherapy

Locations (20)

City of Hope Corona
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States