Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer

Study Overview
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Brief Summary
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This study aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.

Detailed Description
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The SUSPECT2 study is a modified concept from the first SUSPECT study (N14SUS). The first study investigated whether lymph drainage mapping (LDM) using SPECT/CT was a safe and feasible method to exclude the contralateral neck from irradiation, or, in case of contralateral lymph drainage, to tailor the contralateral ENI field to the level containing the tracer accumulation. In this study, large dose reductions to most organs at risk were realized, as well as significant reductions of both short term (mucositis, dysphagia) and long term (xerostomia, dysphagia) toxicities. Firstly, the SUSPECT2 study aims to expand the inclusion criteria of the original SUSPECT study. Secondly, it aims to further reduce the proportion of patients that undergoes bilateral ENI, by performing a contralateral sentinel node procedure (SNP) in case of contralateral lymph drainage. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.

Official Title
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Mapping of Sentinel Lymph Node Drainage Using SPECT/CT to Tailor Highly Selective Elective Nodal Irradiation in Node-negative Neck of Patients With Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Unilateral elective nodal irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed and histopathologically proven primary HNSCC T1-4N0-2b Tumor does not cross midline WHO performance status 0 or 1 Signed written informed consent Exclusion Criteria: Distant metastatic spread at the time of inclusion Chemotherapy or surgery (for the present tumor), prior to inclusion Previous radiation treatment in the head and neck region, for any reason Previous neck dissection Recurrent or second primary tumor in the head and neck region Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus Pregnancy or no active contraception for pre-menopausal women Known hypersensitivity to iodine or nanocolloid injection Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral elective nodal irradiation<br>Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure. | Radiation: Unilateral elective nodal irradiation<br>* After injection of nanocolloid tracer submucosally around the tumor, patients undergo lymph drainage mapping (LDM) using SPECT/CT. If no contralateral drainage is visualized, the patient receives unilateral elective nodal irradiation (ENI). In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed. If pathologic evaluation finds no metastasis, the patient receives unilateral ENI. If (micro/macro) metastasis are found, the patient will receive bilateral ENI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contralateral regional failure | Cumulative incidence of contralateral regional metastasis. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment toxicity | Physician-rated early and late treatment toxicity (CTCAE v5.0) | Until 2 years after end of radiotherapy | 
| Health-related quality of life | Health-related quality of life after treatment (EORTC QLQ-C30/HN35) | Until 18 months after end of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation