Clinical trial NCT05451004: SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
Official title: SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Oropharyngeal Cancer
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: Alliance for Clinical Trials in Oncology
name: Eastern Cooperative Oncology Group
name: NRG Oncology
name: SWOG Cancer Research Network
First posted: 2022-07-11
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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: 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)

Primary outcomes:
measure: Disease-free Survival
timeFrame: 8 years
Secondary outcomes:
measure: Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)
timeFrame: 8 years
measure: Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)
timeFrame: 8 years
measure: Isolated contralateral neck failure (iCNF)
timeFrame: 8 years
measure: Overall Survival (OS)
timeFrame: 8 years
measure: Logo-regional Failure (LRF)
timeFrame: 8 years
measure: Distant Metastases (DM)
timeFrame: 8 years
measure: Incidence and Severity of Radiation-related Toxicities
timeFrame: 8 years
measure: Patient-Reported Toxicities using PRO CTCAE
timeFrame: 8 years
measure: Gastrostomy Tube Usage
timeFrame: 8 years
measure: Resource Utilization
timeFrame: 8 years
measure: Lost Productivity
timeFrame: 8 years
measure: Financial Toxicity [Financial Index of Toxicity (FIT)]
timeFrame: 8 years
measure: Health Utilities using EQ-5D
timeFrame: 8 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center-International Plaza
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center - McKinley Campus
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Cancer Center Warrenville
state: Illinois
city: Louisville
country: United States
facility: The James Graham Brown Cancer Center at University of Louisville
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Brighton
country: United States
facility: University of Michigan - Brighton Center for Specialty Care
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Conroe
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson West Houston
state: Texas
city: League City
country: United States
facility: MD Anderson League City
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre- Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
state: Quebec
Study officials:
affiliation: University Health Network, Princess Margaret Hospital, Toronto ON Canada
name: John R de Almeida
role: STUDY_CHAIR
affiliation: University Health Network, Princess Margaret Hospital, Toronto ON Canada
name: Ali Hosni
role: STUDY_CHAIR
References: