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Trial record 1 of 1 for:    NCT03968679
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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Unilateral elective nodal irradiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Contralateral regional failure [ Time Frame: 1 year ]
    Cumulative incidence of contralateral regional metastasis.


Secondary Outcome Measures :
  1. Treatment toxicity [ Time Frame: Until 2 years after end of radiotherapy ]
    Physician-rated early and late treatment toxicity (CTCAE v5.0)

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Abrahim Al-Mamgani, MD, PhD +31205129111 a.almamgani@nki.nl
Contact: Pieter D de Veij Mestdagh, MD +31205129111 p.d.veij@nki.nl

Locations
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Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Abrahim Al-Mamgani, MD, PhD    +31 20 512 9111    a.almamgani@nki.nl   
Contact: Pieter de Veij Mestdagh, MD    +31 20 512 9111    p.d.veij@nki.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03968679    
Other Study ID Numbers: M19SUS
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
head and neck cancer
lymph drainage mapping
sentinel node procedure
radiotherapy
unilateral elective neck irradiation
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms