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NCT05451004 | RECRUITING | Oropharyngeal Cancer

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

Canadian Cancer Trials Group

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?

Condition or disease

Oropharyngeal Cancer

Intervention/treatment

Lymphatic Mapping with SPECT-CT

Ipsilateral and Contralateral Neck

Phase

PHASE3

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
Estimated Enrollment : 510 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial
Actual Study Start Date : 2023-02-10
Estimated Primary Completion Date : 2030-08-30
Estimated Study Completion Date : 2031-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer

Location Details

NCT05451004

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

RECRUITING

United States, Florida

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States, 32207

RECRUITING

United States, Florida

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Florida

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States, 33607

RECRUITING

United States, Florida

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States, 33612

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Georgia

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

RECRUITING

United States, Kentucky

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Road cancer

University of Michigan Comprehensive Cancer Center

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Road cancer

University of Michigan - Brighton Center for Specialty Care

Brighton, Road cancer, United States, 48116

RECRUITING

United States, Road cancer

Henry Ford Hospital

Detroit, Road cancer, United States, 48202

RECRUITING

United States, North Carolina

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, Oregon

Providence Portland Medical Center

Portland, Oregon, United States, 97213

RECRUITING

United States, Texas

MD Anderson in The Woodlands

Conroe, Texas, United States, 77384

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

MD Anderson West Houston

Houston, Texas, United States, 77079

RECRUITING

United States, Texas

MD Anderson League City

League City, Texas, United States, 77573

RECRUITING

United States, Texas

MD Anderson in Sugar Land

Sugar Land, Texas, United States, 77478

RECRUITING

Canada, Ontario

Health Sciences North

Sudbury, Ontario, Canada, P3E 5J1

SUSPENDED

Canada, Ontario

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

RECRUITING

Canada, Ontario

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

CHUM - Center Hospitalier de l'Iniversité de Montreal

Montreal, Quebec, Canada, H2X 3E4

RECRUITING

Canada, Quebec

Sherbrooke-Fleurimont University Hospital Center

Sherbrooke, Quebec, Canada, J1H 5N4