Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer (SUSPECT-2)
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|ClinicalTrials.gov Identifier: NCT03968679|
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Radiation: Unilateral elective nodal irradiation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 22, 2019|
|Estimated Primary Completion Date :||August 1, 2024|
|Estimated Study Completion Date :||August 1, 2025|
Experimental: Unilateral elective nodal irradiation
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
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.
- Contralateral regional failure [ Time Frame: 1 year ]Cumulative incidence of contralateral regional metastasis.
- Treatment toxicity [ Time Frame: Until 2 years after end of radiotherapy ]Physician-rated early and late treatment toxicity (CTCAE v5.0)
- Health-related quality of life [ Time Frame: Until 18 months after end of radiotherapy ]Health-related quality of life after treatment (EORTC QLQ-C30/HN35)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968679
|Contact: Abrahim Al-Mamgani, MD, PhDemail@example.com|
|Contact: Pieter D de Veij Mestdagh, MDfirstname.lastname@example.org|
|Principal Investigator:||Abrahim Al-Mamgani, MD, PhD||The Netherlands Cancer Institute|