NCT07241273

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

SELECT-FR is a national, randomized, phase II, non-comparative trial. Patients aged 18 or over, with lateralized oropharyngeal squamous cell carcinoma (tonsil, soft palate, pharyngeal wall or tongue base) not involving or crossing midline, Human Papilloma Virus (HPV) positive or negative, T1-T3 with no contralateral nodes or nodes \> 6 cm on Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or Positron Emission Tomography-Computed Tomography (PET-CT). Eligible subjects will be randomized at a 1:1 ratio into the experimental and control arms. * Experimental arm: Patients will receive definitive RT to the primary tumour and ipsilateral neck nodes, while contralateral neck RT treatment will be guided by lymphatic mapping with SPECT-CT. * Control arm: Patients will receive definitive RT to the primary tumour and bilateral neck nodes (Note: candidates for standard unilateral neck RT are not eligible). Randomization will be stratified by the following factors: * Anatomical location of primary tumour: lateral vs. intermediate vs. medial. * HPV status (p16 immunohistochemistry) and smoking status: p16 positive ≤ 10 pack year vs. p16 positive \> 10 pack year vs. p16 negative any. * Extent of disease: limited vs. other: * p16 positive: limited \[T1-T2, N0-N1 (single node \< 3cm without radiologic extranodal extension)\] vs. other. * p16 negative: limited \[T1-T2, N0-N1 (without radiologic extranodal extension)\] vs. other. * Use of concurrent systemic therapy: yes vs. no. In both arms, time from randomization to initiation of RT will be no longer than 6 weeks. Patients will receive RT with or without standard concurrent chemotherapy in either standard fractionation (7 weeks) or altered fractionation (6 weeks). In both arms, all patients will be followed by local investigator as follow: * Treatment period: every week. * Follow-up period: every 3 months until 24 months after treatment and then every 6 months until 36 months after treatment.

Conditions

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

Interventions

Type	Name	Description
OTHER	Lymphatic mapping with SPECT-CT	Lymphatic mapping with SPECT-CT
RADIATION	Bilateral neck radiotherapy	Patients will receive definitive radiotherapy to the primary tumour and bilateral neck nodes.
RADIATION	Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2031-04-01
• First posted: 2025-11-21
• Last updated: 2026-03-24

Locations

12 sites across 1 country: France