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.
Patients must have signed a written informed consent form prior to any trial specific procedures.
Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N1. For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and/or clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.
HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.
Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.
Patients with 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.
Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.
Previous head and neck cancer or multiple synchronous primary head and neck cancers.
Previous induction or neo-adjuvant chemotherapy.
Parallel
Lymphatic mapping with SPECT-CT
Other interventionLymphatic 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.
Two-years Disease Free Survival (DFS) rate
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.
Disease free survival
Disease-free survival (DFS) is defined as time from randomization to the date of first record of any of the following events including local, regional, or distant recurrence or death from any cause. DFS will be censored on the date of last visit with disease assessment.
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. The follow-up of subjects still alive will be censored at the date of last visit/contact.
Isolated Contralateral Neck Failure (iCNF)
Isolated Contralateral Neck Failure (iCNF) is defined as the time from the date of randomization to the date of iCNF. Local ipsilateral neck failure, or distant failure diagnosed concurrently with iCNF or before are not considered events of interest but as competing risks events in the analysis of this endpoint. Subjects without any of the listed events (i.e. events of interest or competing risks events) are censored at the date of the most recent follow-up examination.
Local-regional failure (LRF)
Local-regional failure (LRF) is defined as the time from the date of randomization to the date of any local or regional failure. Distant recurrence/progression diagnosed before local or regional failure are not considered events of interest, but as competing risks events in the analysis of this endpoint. Subjects without any of the listed events (i.e. events of interest or competing risks events) are censored at the date of the most recent follow-up examination.
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UNICANCER
Lead sponsor
National Cancer Institute, France
Collaborator
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