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Studies

Interventional Not yet recruiting

NCT07241273 on ClinicalTrials.gov

SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer

Official title: SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial

  • Sponsor: Unicancer
  • Collaborators: National Cancer Institute, France
  • Enrollment: 128 (Estimated)
  • Study start: 2026-09-01 (Estimated)
  • Primary completion: 2030-09-01 (Estimated)
  • Study completion: 2031-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Investigator)
  • PrimaryPurpose: Treatment

Brief Summary

Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.

Lymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.

The goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.

Conditions

  • Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Cancers
  • Oropharyngeal Carcinoma
  • Head and Neck
  • Head and Neck Cancer
  • Head and Neck Cancers

Intervention / Treatment

  • Other: Lymphatic mapping with SPECT-CT
  • Radiation: Bilateral neck radiotherapy
  • Radiation: Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy

Primary Outcome Measures

  • Two-years Disease Free Survival (DFS) rate (At 2 years after treatment)
    The primary endpoint is 2 year-Disease-Free Survival rate (2y-DFS) defined as patients free of disease at two years. Patients without any event before 2 years will be considered as success, patients lost to follow-up before 2 years will be considered as failure.

Countries

France

Locations and Investigators

  • CHU Brest, Brest, France
    • Ulrike SCHICK, MD
  • Centre François Baclesse, Caen, France
    • Juliette THARIAT, MD
  • CHU Caen, Caen, France
    • Emmanuel BABIN, MD
  • Centre Georges François Leclerc, Dijon, France
    • Noémie VULQUIN, MD
  • Centre de Radiothérapie Guillaume Le Conquérant, Le Havre, France
    • Laurent MARTIN, MD
  • Centre Oscar Lambret, Lille, France
    • Xavier LIEM, MD
  • Institut Régional du Cancer de Montpellier, Montpellier, France
    • Pierre BOISSELIER, MD
  • Hôpital Tenon, Paris, France
    • Florence HUGUET, MD
  • Centre Henri Becquerel, Rouen, France
    • Sébastien THUREAU, MD
  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre, Strasbourg, France
    • Philippe SCHULTZ, MD
  • Institut de Cancérologie Strasbourg Europe, Strasbourg, France
    • Jordan EBER, MD
  • CHRU Tours - Hôpital Bretonneau, Tours, France
    • Sofia BAKKAR, MD

Study Officials