Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS

SCCHN Clinical Trial

— QDV2b  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878655
• Other study ID #: 14-059
• Status: Recruiting
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Caen
• Contact: Roger VIVIEN, MD
• Email: babin-e[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.

Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.

In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with SCCHN histologically proven N0 clinical and radiological

• Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx

• Patient candidate for a neck dissection fonctonnel

• Life expectancy> 3 months

• Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia

• Age over 18 ans

• Patient was informed of the study

• Patient fluent French

Exclusion Criteria:

• Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured

• Patient has at the time of examination of recurrence of signs or other scalable neoplasia

• Uncontrolled Infectious diseases

• Neoadjuvant radiotherapy

• Patient nursing or pregnant or lack of contraception during their reproductive

• Intercurrent pathology involving life-threatening

• Any medical or psychological condition associated that could compromise the patient's ability to participate in the study

• Inability to submit to medical follow-up study for geographical, social or psychic

Related Conditions & MeSH terms

• SCCHN

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Annalogue Scale for Global Quality of Life	(rate between 0 and 10)	change over baseline and month 6