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 - SUSPECT-2
- Conditions
- Head and Neck Cancer10027655
- Registration Number
- NL-OMON54554
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
• Newly diagnosed and histopathologically proven lateralized primary HNSCC,
T1-4N0-2b without midline involvement, originating at one side of the oral
cavity, oropharynx, larynx (except T1 glottic), and hypopharynx, and planned
for treatment with primary radiotherapy, chemo-radiotherapy or
immuno-radiotherapy in curative setting
• Age >= 18 years
• WHO performance status 0 or 1
• Signed written informed consent
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cumulative incidence of contralateral regional metastasis at 1 year after<br /><br>treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Toxicity<br /><br>Quality of Life<br /><br>Prevalence of metastatic disease in contralateral sentinel nodes removed based<br /><br>on lymph drainage mapping using SPECT/CT at baseline</p><br>