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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05746780
Other study ID # 3364
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date March 1, 2021

Study information

Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion criteria -patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI). Exclusion Criteria: - patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.

Study Design


Intervention

Procedure:
Elective bilateral neck dissection in cN0 patients
Radical modified type 3 selective bilaterale elective neck dissection

Locations

Country Name City State
Italy Stefano Settimi Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occult lymph node metastasis Incidence rate of occult lymph node metastasislaryngectomy with clinically negative lymph nodes (cN0), estimating the prevalence of histologically positive lymph nodes (pN+) and predictive factors for cervical lymph nodes metastasis At the time of salvage surgery
Secondary Complications of bilateral neck dissection during hospitalization Complications of bilateral neck dissection during hospitalization Up to 15 days from salvage surgery
Secondary Overall survival Survival of the patient from any disease 5 year
Secondary Disease specific survival Survival of the patient from laryngeal disease 5 years
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