Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Radiation: Unilateral elective nodal irradiation
- Registration Number
- NCT03968679
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unilateral elective nodal irradiation 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.
- Primary Outcome Measures
Name Time Method Contralateral regional failure 1 year Cumulative incidence of contralateral regional metastasis.
- Secondary Outcome Measures
Name Time Method Health-related quality of life Until 18 months after end of radiotherapy Health-related quality of life after treatment (EORTC QLQ-C30/HN35)
Treatment toxicity Until 2 years after end of radiotherapy Physician-rated early and late treatment toxicity (CTCAE v5.0)
Trial Locations
- Locations (1)
Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands