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Open Access 01-12-2019 | Radiotherapy | Study protocol

Mapping of sentinel lymph node drainage using SPECT/CT to tailor elective nodal irradiation in head and neck cancer patients (SUSPECT-2): a single-center prospective trial

Authors: Pieter D. de Veij Mestdagh, Willem H. Schreuder, Wouter V. Vogel, Maarten L. Donswijk, Eric van Werkhoven, Jacqueline E. van der Wal, Richard Dirven, Baris Karakullukcu, Jan-Jakob Sonke, Michiel W. M. van den Brekel, Corrie A. M. Marijnen, Abrahim Al-Mamgani

Published in: BMC Cancer | Issue 1/2019

Abstract

Background

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. 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.

Methods

In 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.

Discussion

This 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 registration

ClinicalTrials.gov Identifier: NCT03968679, date of registration: May 30, 2019.

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Title: Mapping of sentinel lymph node drainage using SPECT/CT to tailor elective nodal irradiation in head and neck cancer patients (SUSPECT-2): a single-center prospective trial
Authors: Pieter D. de Veij Mestdagh
Willem H. Schreuder
Wouter V. Vogel
Maarten L. Donswijk
Eric van Werkhoven
Jacqueline E. van der Wal
Richard Dirven
Baris Karakullukcu
Jan-Jakob Sonke
Michiel W. M. van den Brekel
Corrie A. M. Marijnen
Abrahim Al-Mamgani
Publication date: 01-12-2019
Publisher: BioMed Central
Keyword: Radiotherapy
Published in: BMC Cancer / Issue 1/2019
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-019-6331-8

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