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

May 13, 2024 updated by: Canadian Cancer Trials Group

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 416-480-5000
        • Principal Investigator:
          • Antoine Eskander
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Ali Hosni
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
        • Contact:
        • Principal Investigator:
          • Isabelle Gauthier
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 904-202-7468
        • Principal Investigator:
          • Omar M. Mahmoud
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Gregory J. Kubicek
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center-International Plaza
        • Contact:
        • Principal Investigator:
          • Krupal B. Patel
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Contact:
        • Principal Investigator:
          • Krupal B. Patel
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Krupal B. Patel
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Jill Remick
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Katelyn Stepan
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Katelyn Stepan
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Steven B. Chinn
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Principal Investigator:
          • Steven B. Chinn
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Xuguang Chen
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Anna Lee
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Anna Lee
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Anna Lee
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Anna Lee
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Anna Lee

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lympathic Mapping with SPECT-CT guided Radiotherapy
Other: Lymphatic Mapping with SPECT-CT
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy
Active Comparator: Bilateral Neck Radiotherapy
Radiation: Ipsilateral and Contralateral Neck
Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free Survival
Time Frame: 8 years
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)
Time Frame: 8 years
Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing).
8 years
Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)
Time Frame: 8 years
Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT
8 years
Isolated contralateral neck failure (iCNF)
Time Frame: 8 years
8 years
Overall Survival (OS)
Time Frame: 8 years
8 years
Logo-regional Failure (LRF)
Time Frame: 8 years
8 years
Distant Metastases (DM)
Time Frame: 8 years
8 years
Incidence and Severity of Radiation-related Toxicities
Time Frame: 8 years
8 years
Patient-Reported Toxicities using PRO CTCAE
Time Frame: 8 years
8 years
Gastrostomy Tube Usage
Time Frame: 8 years
8 years
Resource Utilization
Time Frame: 8 years
8 years
Lost Productivity
Time Frame: 8 years
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
Financial Toxicity [Financial Index of Toxicity (FIT)]
Time Frame: 8 years
8 years
Health Utilities using EQ-5D
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

Alliance for Clinical Trials in Oncology
NRG Oncology
Eastern Cooperative Oncology Group
SWOG Cancer Research Network

Investigators

  • Study Chair: John R de Almeida, University Health Network, Princess Margaret Hospital, Toronto ON Canada
  • Study Chair: Ali Hosni, 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 Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

August 30, 2031

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTG-HN11 (Other Identifier: NCI/CTEP)
  • NCI-2022-04496 (Other Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Based on CCTG Policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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