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Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT) (SUSPECT)

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ClinicalTrials.gov Identifier: NCT02572661
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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Brief Summary:
This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: radiation in Squamous Head and Neck Cancer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 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 to Tailor Highly-Selective Elective Nodal Irradiation in Node-Negative Neck of Patients With Head and Neck Cancer (SUSPECT)
Actual Study Start Date : July 23, 2015
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

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Arms and Interventions
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Arm Intervention/treatment
Squamous Head and Neck Cancer
radiation
 Radiation: radiation in Squamous Head and Neck Cancer


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks [ Time Frame: 12 weeks ]
    mapping of sentinel lymph node drainage to indentify groups at low risk of the probability of contra regionale failure is to be estimated to be 2% at 2 years. A recurrrence rate of >15% will be assumed unacceptable


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 patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
  • No chemotherapy or surgery prior to inclusion
  • No distant metastatic spread at the time of inclusion
  • Age ≥ 18 years
  • WHO performance status 0 or 1
  • Signed written informed consent

Exclusion Criteria:

  • Patients with previously radiation treatment in the head and neck region, for any reason
  • Patients with previous neck dissection
  • Patients with recurrent or second primary tumor in the head and neck region
  • Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
  • Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
  • 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
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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): NCT02572661


Locations
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Netherlands
the Netherlands Cancer Instiute
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02572661    
Other Study ID Numbers: N14SUS
N14SUS ( Registry Identifier: PTC )
NL51706.031.14 ( Registry Identifier: CCMO )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Keywords provided by The Netherlands Cancer Institute:
Radiotherapy, Sentinel Node Mapping, Spect
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms