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

Head and Neck Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572661
• Other study ID #: N14SUS
• Secondary ID: N14SUSNL51706.03
• Status: Completed
• Phase: N/A
• Start date: July 23, 2015
• Est. completion date: November 9, 2018

Study information

• Verified date: June 2019
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• radiation in Squamous Head and Neck Cancer

Locations

Country	Name	City	State
Netherlands	the Netherlands Cancer Instiute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks