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

Sponsor
UNICANCER
Study ID
NCT07241273
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lymphatic mapping with SPECT-CT — OTHER
    Lymphatic mapping with SPECT-CT
  • Bilateral neck radiotherapy — RADIATION
    Patients will receive definitive radiotherapy to the primary tumour and bilateral neck nodes.
  • Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy — RADIATION
    Patients will receive definitive radiotherapy to the primary tumour and ipsilateral neck nodes while radiotherapy to the contralateral neck nodes will be guided by lymphatic mapping with SPECT-CT.

Study Details

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.

Key Dates

First listed
Nov 21, 2025
Start date
Sep 30, 2026
Status verified
Oct 2025
Primary completion
Sep 30, 2030
Completion
Sep 30, 2031

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy
    Radiotherapy of ipsilateral neck nodes \& Radiotherapy of the contralateral neck nodes guided by SPECT-CT
  • Active Comparator: Bilateral neck radiotherapy
    Radiotherapy of nodes on both sides of the neck

Primary Outcome Measure

Two-years Disease Free Survival (DFS) rate [ Time Frame: At 2 years after treatment ]

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