DRKS00022304
Recruiting
N/A
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 - SentiNose Pilot
niversitätsklinikum Ulm, Kliniken am oberen Eselsberg0 sites25 target enrollmentNovember 13, 2020
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- C30.0
- Sponsor
- niversitätsklinikum Ulm, Kliniken am oberen Eselsberg
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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