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QDV2b: Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT02878655
Collaborator
(none)
60
Enrollment
1
Location
46
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Feb 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Visual Annalogue Scale for Global Quality of Life [change over baseline and month 6]

      (rate between 0 and 10)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Caen University Hospital Caen France 14000

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT02878655
    Other Study ID Numbers:
    • 14-059
    First Posted:
    Aug 25, 2016
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Jul 1, 2018
    Keywords provided by University Hospital, Caen
    N0 clinical and radiological
    dissection IIb sector

    Study Results

    No Results Posted as of Jul 18, 2018