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

Head and Neck Cancer Clinical Trial

— SUSPECT-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968679
• Other study ID #: M19SUS
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: August 1, 2028

Study information

• Verified date: June 2024
• Source: The Netherlands Cancer Institute
• Contact: Abrahim Al-Mamgani, MD, PhD
• Phone: +31205129111
• Email: a.almamgani[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contralateral regional failure	Cumulative incidence of contralateral regional metastasis.	1 year
Secondary	Treatment toxicity	Physician-rated early and late treatment toxicity (CTCAE v5.0)	Until 2 years after end of radiotherapy
Secondary	Health-related quality of life	Health-related quality of life after treatment (EORTC QLQ-C30/HN35)	Until 18 months after end of radiotherapy