Inoperable Squamous Cell Cancer of the Head and NeckELAN-ONCOVALNCT03614936
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
An observational study of Inoperable Squamous Cell Cancer of the Head and Neck, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Inoperable Squamous Cell Cancer of the Head and Neck
- What is being tested?
- Geriatric Screening Test G8 and Geriatric fragility test GERICO
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2013to Jun 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Older adult
Study population: Patients 70 years of age or older with ENT carcinoma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94805
Anne AUPERIN, MD, 0142114211 ext. +33, anne.auperin@gustaveroussy.fr
About this study
Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation
- Being tested
- Geriatric Screening Test G8, Geriatric fragility test GERICO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Screening Test G8Other
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 GERICOOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Inoperable squamous cell cancer of the head and neck | patients 70 years of age or older with ENT carcinoma Receives: Other: Geriatric Screening Test G8; Other: Geriatric fragility test GERICO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start11 Jun 2013
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable Squamous Cell Cancer of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel GUIGAY, MD, PhD, Study chair, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614936
- Sponsor's protocol ID
- 2012-A00888-35
- Other IDs
- 2013/1962
- Acronym
- ELAN-ONCOVAL
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03614936
- Acronym / sponsor ID
- ELAN-ONCOVAL / 2012-A00888-35
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 11 Jun 2013 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inoperable squamous cell cancer of the head and neck | – | Other: Geriatric Screening Test G8, Other: Geriatric fragility test GERICOpatients 70 years of age or older with ENT carcinoma |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients 70 years of age or older with ENT carcinoma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Screening Test G8Geriatric 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 | Inoperable squamous cell cancer of the head and neck |
| Geriatric fragility test GERICOGERICO 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) | Other | Inoperable squamous cell cancer of the head and neck |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel GUIGAY, MD, PhD study chair
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inoperable Squamous Cell Cancer of the Head and Neck, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joel GUIGAY, MD, PhD (0492031501 ext. +33, joel.guigay@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.