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出境医 / 临床实验 / Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer (SUSPECT-2)

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

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.

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.

Study Design
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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
Arms and Interventions
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.
Outcome Measures
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)


Eligibility Criteria
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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
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for investigator information
Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019) 		Contralateral regional failure [ Time Frame: 1 year ]
Cumulative incidence of contralateral regional metastasis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Radiation: Unilateral elective nodal irradiation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2025
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abrahim Al-Mamgani, MD, PhD +31205129111 a.almamgani@nki.nl
Contact: Pieter D de Veij Mestdagh, MD +31205129111 p.d.veij@nki.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968679
Other Study ID Numbers  ICMJE M19SUS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute
PRS Account The Netherlands Cancer Institute
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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