A prospective pilot study on the safety and feasibility of sentinel node biopsy in the neck management of conventionally assessed lymph node negative sinonasal squamous cell carcinoma
- Conditions
- C30.0C31Nasal cavityMalignant neoplasm of accessory sinuses
- Registration Number
- DRKS00022304
- Lead Sponsor
- niversitätsklinikum Ulm, Kliniken am oberen Eselsberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
• Histologically proven malignancy of the nasal vestibulum and the sinonasal tract; T1-3, N0, M0; squamous cell carcinoma
• Primary tumor must be resectable endoscopically or via limited open approach without changing the facial appearance
• Written and signed informed consent
• ECOG PS =2, Karnofsky PS = 60 %
• Age = 18
• Curative treatment intent
• Prior head and neck malignancy
• Entity other than squamous cell carcinoma
• Clinically suspected lymph node or distant metastases
• Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C
• Hemoglobin level < 9.5 g/dl
• Pregnancy or lactation
• Prior treatment of the neck of any cause
• Concurrent treatment with experimental drugs or participation in another clinical trial of any kind within 30 days prior to study screening
• Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol
• Patients institutionalized by official means or court order
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical morbidity, Lymph node metastasis detection rate by sentinel node biopsy, Duration of hospitalization, Feasibility of PET/MR scan before surgery
- Secondary Outcome Measures
Name Time Method Time to regional metastasis, Time to death of any cause, Time to distant metastasis, Concordance of PET/MR positive and sentinel lymph nodes, Prognostic value of PET/MR data. Follow-up will be up to 5 years.