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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: radiation in Squamous Head and Neck Cancer

• Registration Number: NCT02572661
• Lead Sponsor: The Netherlands Cancer Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-22
• Study Start: 2015-07-23
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Squamous Head and Neck Cancer	radiation in Squamous Head and Neck Cancer	radiation

Primary Outcome Measures

Name	Time	Method
Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks	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

Trial Locations

Locations (1)

the Netherlands Cancer Instiute; 🇳🇱 Amsterdam, Netherlands