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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
radiation in Squamous Head and Neck Cancer
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 Radiotherapy, Sentinel Node Mapping, Spect

Eligibility Criteria

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

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

Sites / Locations

  • the Netherlands Cancer Instiute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Squamous Head and Neck Cancer

Arm Description

radiation

Outcomes

Primary Outcome Measures

Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 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

Secondary Outcome Measures

Full Information

First Posted
December 22, 2014
Last Updated
June 26, 2019
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02572661
Brief Title
Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)
Acronym
SUSPECT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2015 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Radiotherapy, Sentinel Node Mapping, Spect

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Squamous Head and Neck Cancer
Arm Type
Other
Arm Description
radiation
Intervention Type
Radiation
Intervention Name(s)
radiation in Squamous Head and Neck Cancer
Primary Outcome Measure Information:
Title
Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
the Netherlands Cancer Instiute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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