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

Oropharyngeal Cancer Clinical Trial

— SELECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451004
• Other study ID #: CCTG-HN11
• Secondary ID: CCTG-HN11NCI-202
• Status: Recruiting
• Phase: Phase 3
• Start date: February 10, 2023
• Est. completion date: August 30, 2031

Study information

• Verified date: March 2024
• Source: Canadian Cancer Trials Group
• Contact: Wendy Parulekar
• Phone: 613-533-6430
• Email: wparulekar[@]ctg.queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: August 30, 2031
• Est. primary completion date: August 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Other:
• Lymphatic Mapping with SPECT-CT
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy

Radiation:
• Ipsilateral and Contralateral Neck
Radiotherapy

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec
Canada	Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	University of Michigan - Brighton Center for Specialty Care	Brighton	Michigan
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	MD Anderson in The Woodlands	Conroe	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	MD Anderson West Houston	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	MD Anderson League City	League City	Texas
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Providence Portland Medical Center	Portland	Oregon
United States	MD Anderson in Sugar Land	Sugar Land	Texas
United States	Moffitt Cancer Center	Tampa	Florida
United States	Moffitt Cancer Center - McKinley Campus	Tampa	Florida
United States	Moffitt Cancer Center-International Plaza	Tampa	Florida
United States	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, NRG Oncology, SWOG Cancer Research Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival		8 years
Secondary	Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)	Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing).	8 years
Secondary	Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)	Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT	8 years
Secondary	Isolated contralateral neck failure (iCNF)		8 years
Secondary	Overall Survival (OS)		8 years
Secondary	Logo-regional Failure (LRF)		8 years
Secondary	Distant Metastases (DM)		8 years
Secondary	Incidence and Severity of Radiation-related Toxicities		8 years
Secondary	Patient-Reported Toxicities using PRO CTCAE		8 years
Secondary	Gastrostomy Tube Usage		8 years
Secondary	Resource Utilization		8 years
Secondary	Lost Productivity	Healthcare system and societal resources will be quantified over the course of the trial to generate utilization information by patient in each study arm. We will generate an average cost per study subject by treatment arm for an overall mean cost per study arm	8 years
Secondary	Financial Toxicity [Financial Index of Toxicity (FIT)]		8 years
Secondary	Health Utilities using EQ-5D		8 years