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

Inoperable Squamous Cell Cancer of the Head and Neck Clinical Trial

— ELAN-ONCOVAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614936
• Other study ID #: 2012-A00888-35
• Secondary ID: 2013/1962
• Status: Recruiting
• Start date: June 11, 2013
• Est. completion date: June 2019

Study information

• Verified date: July 2018
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Joel GUIGAY, MD, PhD
• Phone: 0492031501
• Email: joel.guigay[@]nice.unicancer.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Inoperable Squamous Cell Cancer of the Head and Neck
• Neoplasms, Squamous Cell

Intervention

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).
• 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)

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate	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