Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

• Conditions: Oropharyngeal Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

• Registration Number: NCT03727594
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2018-07-08
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Study First Posted: 2018-11-01
• Last Update Posted: 2018-11-01
• Primary Completion: 2020-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• accepted informed consent
• preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
• patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)

Exclusion Criteria

• rejected informed consent
• patients not fit to surgery (according to the general health condition and the clinical tumor stage)
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy	5 years
Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins	5 years
Disease-free survival	5 years	Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.

Trial Locations

Locations (1)

University Hospital of Ferrara; 🇮🇹 Ferrara, Italy