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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral elective nodal irradiation | Experimental | Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral elective nodal irradiation | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Contralateral regional failure | Cumulative incidence of contralateral regional metastasis. | 1 year |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abrahim Al-Mamgani, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | 1066 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31727019 | Derived | de Veij Mestdagh PD, Schreuder WH, Vogel WV, Donswijk ML, van Werkhoven E, van der Wal JE, Dirven R, Karakullukcu B, Sonke JJ, van den Brekel MWM, Marijnen CAM, Al-Mamgani A. 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. BMC Cancer. 2019 Nov 14;19(1):1110. doi: 10.1186/s12885-019-6331-8. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Until 18 months after end of radiotherapy |