Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck (ELAN-ONCOVAL)

July 30, 2018 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 70 years of age or older with ENT carcinoma

Description

Inclusion Criteria:

  • Subject aged 70 or over
  • Carrier of squamous cell carcinoma of the head and neck, locally advanced undergoing treatment by radiotherapy or metastatic / recurrence not accessible to treatment curative locoregional under treatment with chemotherapy.
  • Patient likely to be eligible for ELAN-RT or ELAN-FIT or ELAN-UNFIT trials.
  • Patients affiliated to a social security scheme

Exclusion Criteria:

  • Person deprived of liberty or under guardianship,
  • Presence of a neuro-psychological condition, family, social, or geographical, which may hinder the smooth running of the study.
  • Patient expressing opposition to participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inoperable squamous cell cancer of the head and neck
patients 70 years of age or older with ENT carcinoma
Other: Geriatric Screening Test G8
Geriatric screening test (Oncodage-G8). The oncologist realizes it and proposes the oncological treatment which seems to him then the most adapted (treatment which can be different from that proposed after the oncological evaluation only).
Other: Geriatric fragility test GERICO

GERICO geriatric frailty test (if possible the same day as the G8 and in any case in the same week): Realized by the oncologist, it includes:

  • the socio-cultural evaluation scale,
  • the ADL autonomy questionnaire,
  • assessment of locomotor disorders,
  • nutritional assessment,
  • the MMSE Cognitive Function Evaluation Questionnaire,
  • the GDS-4 mood rating scale,
  • the comorbidity assessment test (Charlson Index)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion rate
Time Frame: Up to 1 year
Rate of completion of each of the geriatric fragility test questionnaires and the G8 questionnaire and duration of the geriatric evaluation performed by the oncologist
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Study Chair: Joel GUIGAY, MD, PhD, Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 11, 2013

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (ACTUAL)

August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00888-35
  • 2013/1962 (OTHER: CSET number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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