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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2031-08-30

Brief Summary

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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

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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

Conditions

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Oropharyngeal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lympathic Mapping with SPECT-CT guided Radiotherapy

Group Type EXPERIMENTAL

Lymphatic Mapping with SPECT-CT

Intervention Type OTHER

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

Bilateral Neck Radiotherapy

Group Type ACTIVE_COMPARATOR

Ipsilateral and Contralateral Neck

Intervention Type RADIATION

Radiotherapy

Interventions

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Lymphatic Mapping with SPECT-CT

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

Intervention Type OTHER

Ipsilateral and Contralateral Neck

Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John R de Almeida

Role: STUDY_CHAIR

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Ali Hosni

Role: STUDY_CHAIR

University Health Network, Princess Margaret Hospital, Toronto ON Canada

NCI-2022-04496

Identifier Type: OTHER

Identifier Source: secondary_id

CCTG-HN11

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Lympathic Mapping with SPECT-CT guided Radiotherapy

Lymphatic Mapping with SPECT-CT

Bilateral Neck Radiotherapy

Ipsilateral and Contralateral Neck

Interventions

Lymphatic Mapping with SPECT-CT

Ipsilateral and Contralateral Neck

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Alliance for Clinical Trials in Oncology

Eastern Cooperative Oncology Group

NRG Oncology

SWOG Cancer Research Network

Canadian Cancer Trials Group

Responsible Party

Principal Investigators

John R de Almeida

Ali Hosni

Locations

City of Hope Corona

City of Hope Comprehensive Cancer Center

UM Sylvester Comprehensive Cancer Center at Coral Gables

Baptist MD Anderson Cancer Center

University of Miami Miller School of Medicine-Sylvester Cancer Center

Moffitt Cancer Center-International Plaza

Moffitt Cancer Center - McKinley Campus

Moffitt Cancer Center

Emory University Hospital Midtown

Northwestern University

Northwestern Medicine Cancer Center Warrenville

The James Graham Brown Cancer Center at University of Louisville

University of Michigan Comprehensive Cancer Center

University of Michigan - Brighton Center for Specialty Care

Henry Ford Hospital

MU Health - University Hospital/Ellis Fischel Cancer Center

UNC Lineberger Comprehensive Cancer Center

Providence Portland Medical Center

MD Anderson in The Woodlands

M D Anderson Cancer Center

MD Anderson West Houston

MD Anderson League City

MD Anderson in Sugar Land

University of Vermont Medical Center

University of Vermont and State Agricultural College

BCCA-Vancouver Cancer Centre

CancerCare Manitoba

Health Sciences North

Odette Cancer Centre- Sunnybrook Health Sciences Centre

University Health Network-Princess Margaret Hospital

CHUM - Centre Hospitalier de l'Universite de Montreal

Jewish General Hospital

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Countries

Central Contacts

Wendy Parulekar

Facility Contacts

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