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Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer (SUSPECT-2)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Unilateral elective nodal irradiation
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Netherlands Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unilateral elective nodal irradiation

Arm Description

Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure.

Outcomes

Primary Outcome Measures

Contralateral regional failure
Cumulative incidence of contralateral regional metastasis.

Secondary Outcome Measures

Treatment toxicity
Physician-rated early and late treatment toxicity (CTCAE v5.0)
Health-related quality of life
Health-related quality of life after treatment (EORTC QLQ-C30/HN35)

Full Information

First Posted
May 27, 2019
Last Updated
July 3, 2023
Sponsor
The Netherlands Cancer Institute
Collaborators
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03968679
Brief Title
Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral elective nodal irradiation
Arm Type
Experimental
Arm Description
Exclusion of contralateral neck from elective nodal irradiation, based on results of SPECT/CT and (in case of contralateral drainage) contralateral sentinel node procedure.
Intervention Type
Radiation
Intervention Name(s)
Unilateral elective nodal irradiation
Intervention Description
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 Measure Information:
Title
Contralateral regional failure
Description
Cumulative incidence of contralateral regional metastasis.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Treatment toxicity
Description
Physician-rated early and late treatment toxicity (CTCAE v5.0)
Time Frame
Until 2 years after end of radiotherapy
Title
Health-related quality of life
Description
Health-related quality of life after treatment (EORTC QLQ-C30/HN35)
Time Frame
Until 18 months after end of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abrahim Al-Mamgani, MD, PhD
Phone
+31205129111
Email
a.almamgani@nki.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter D de Veij Mestdagh, MD
Phone
+31205129111
Email
p.d.veij@nki.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abrahim Al-Mamgani, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abrahim Al-Mamgani, MD, PhD
Phone
+31 20 512 9111
Email
a.almamgani@nki.nl
First Name & Middle Initial & Last Name & Degree
Pieter de Veij Mestdagh, MD
Phone
+31 20 512 9111
Email
p.d.veij@nki.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31727019
Citation
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.
Results Reference
derived

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

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