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 — OTHERLymphatic mapping with SPECT-CT
- Bilateral neck radiotherapy — RADIATIONPatients will receive definitive radiotherapy to the primary tumour and bilateral neck nodes.
- Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy — RADIATIONPatients 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 radiotherapyRadiotherapy of ipsilateral neck nodes \& Radiotherapy of the contralateral neck nodes guided by SPECT-CT
- Active Comparator: Bilateral neck radiotherapyRadiotherapy 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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