Abstract
BackgroundThe majority of patients with head and neck squamous cell carcinoma (HNSCC) receive bilateral elective nodal irradiation (ENI), in order to reduce the risk of regional failure. Bilateral ENI, as compared to unilateral ENI, is associated with higher incidence of acute and late radiation-induced toxicity with subsequent deterioration of quality of life. Increasing evidence that the incidence of contralateral regional failure (cRF) in lateralized HNSCC is very low (< 10%) suggests that it can be justified to treat selected patients unilaterally. This trial aims to minimize the proportion of patients that undergo bilateral ENI, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation.MethodsIn this one-armed, single-center prospective trial, patients with primary T1-4 N0-2b HNSCC of the oral cavity, oropharynx, larynx (except T1 glottic) or hypopharynx, not extending beyond the midline and planned for primary (chemo) radiotherapy, are eligible. After 99mTc-nanocolloid tracer injection in and around the tumor, lymphatic drainage is visualized using SPECT/CT. In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed on the same day. Patients without contralateral lymph drainage, and patients with contralateral drainage but without pathologic involvement of any removed contralateral sentinel nodes, receive unilateral ENI. Only when tumor cells are found in a contralateral sentinel node the patient will be treated with bilateral ENI. The primary endpoint is cumulative incidence of cRF at 1 and 2 years after treatment. Secondary endpoints are radiation-related toxicity and quality of life. The removed lymph nodes will be studied to determine the prevalence of occult metastatic disease in contralateral sentinel nodes.DiscussionThis single-center prospective trial aims to reduce the incidence and duration of radiation-related toxicities and improve quality of life of HNSCC patients, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation.Trial registrationClinicalTrials.gov Identifier: NCT03968679, date of registration: May 30, 2019.
Highlights
The majority of patients with head and neck squamous cell carcinoma (HNSCC) receive bilateral elective nodal irradiation (ENI), in order to reduce the risk of regional failure
The great majority of patients with head and neck squamous cell carcinoma (HNSCC) receive elective nodal irradiation (ENI) to both sides of the neck in order to reduce the risk of contralateral regional failure
One way to reduce the incidence and severity of these toxicities is by implementation of unilateral ENI, in patients where this can be justified
Summary
Study design This study has a one-arm, single-center prospective trial design. Patients eligible for this study will undergo SPECT/ CT-guided LDM, and based on its findings either unilateral or bilateral ENI will be performed. The following tumor site-based exceptions are included [17]: In patients with node-negative oral cavity cancer only level I-III will be electively irradiated. In case a contralateral SNP was performed but the SN was not identified/detected, the elective irradiation will include the ipsilateral neck plus the contralateral neck level containing the tracer accumulation. Response evaluation The response evaluation will be done according to the institutional guidelines 12 weeks after treatment by physical examination of the neck and primary tumor site, including flexible endoscopy. Eighty percent of patients treated in the study had unilateral lymphatic drainage and were treated only to the ipsilateral neck, and 20% had bilateral lymphatic drainage and were treated with unilateral ENI plus an elective irradiation dose only to the contralateral neck level where the tracer accumulation was seen.
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