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Head and Neck Squamous Cell Carcinomas (HNSCCs)EGéSORNCT02025062

Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients

A study testing CGA and geriatric follow-up in people with Head and Neck Squamous Cell Carcinomas (HNSCCs), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The intervention tested in this research project aims to reduce this inequality by improving the management of elderly head and neck cancer patients with a specific management. Indeed, the treatment of elderly head and neck cancer patients has specificities concerning treatment options, their tolerance, psychological… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
CGA and geriatric follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
499 participants
Where
1 siteFrance
Study dates
Sep 2013to Sep 2020
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • patients aged 65 years old and over (modified by amendment n 2 -1/07/2014)
  • macroscopical lesions suggesting an cancerous tumor in head and neck awaiting pathology confirmation;
  • support in one of ENT/Maxilla-facial surgery departments in the study;
  • patients insured by a social security;
  • patients informed of the study, and having given his non opposition verbally.

Who cannot join

  • patients deprived of liberty or under legal protection;
  • presence of psychological, family, socials or geographic condition(s) that may interfere with the proper conduct of the study;
  • personal history of head and neck cancer except single surgery for squamos cell carcinoma without additional treatment (without curietherapy or RT) with a free interval of at least 5 years (modified by amendment n 2 -1/07/2014)
  • patients with cancerous tumor of sinus and salivary glands

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor

    Créteil, 94000

Other trials in France

About this study

Official title: Impact of Comprehensive Geriatric Assessment on Malnutrition, Functional Status and Survival in Elderly Patients With Head and Neck Squamous Cell Carcinomas (HNSCCs): a Randomized Controlled Multicenter Clinical Trial

The intervention tested in this research project aims to reduce this inequality by improving the management of elderly head and neck cancer patients with a specific management. Indeed, the treatment of elderly head and neck cancer patients has specificities concerning treatment options, their tolerance, psychological management, nutritional and functional status, and support needed at home. To assess the overall needs of the elderly patients, an assessment known as "comprehensive geriatric assessment" (CGA) can be performed by a geriatrician with extensive testing and questionnaires. This assessment is long and requires an experienced geriatrician. It leads to the development of an individualized treatment plan (physiotherapy, psychological follow-up, support at home, nutritional management ...) and follow-up to adapt the necessary cares for the duration of the cancer treatment. The CGA utility has been studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed improving survival and maintaining the elderly at home.

Read the detailed description

Context: The survival of elderly patients with head and neck squamous cell carcinomas (HNSCC) cancer is greatly reduced compared to younger subjects. Several explanations have been proposed : a competitive comorbidity, a more frequent refusal of standard therapy or the choice of a suboptimal treatment due to fear of toxicities. The comprehensive geriatric assessment (CGA) may influence the decision-making process and help for managing elderly patients with head and neck cancer. The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up.

Hypotheses: We postulate that the CGA and the geriatric follow-up improves 1) the therapeutic decision-making process thanks to a better assessment of the patient's functional reserve and its capacity to support or not the treatment, and 2) the overall survival, the functional status and the nutritional status of elderly patients with HNSCC because of a more appropriate treatment and a personalized medical follow-up after surgery and/or radiotherapy and/or chemotherapy or more rarely targeted therapy, with adjustment of treatments and management of comorbidities and/or treatment complications.

Main objective: To assess the impact of the CGA and the geriatric follow-up on the overall survival, the functional status and the nutritional status of elderly patients with HNSCC.

Secondary objectives: To assess the impact of the CGA on the therapeutic decision, the toxicity and/or complications of treatment, the complete realization of treatment, the autonomy, the institutionalization, the total hospitalization stay, the quality of life of elderly patients with HNSCCs and the costs.

Being tested
CGA and geriatric follow-up
Keywords
head and neck squamous cell carcinomas (HNSCCs), elderly, cancer, comprehensive geriatric assessment, functional status, malnutrition, survival
Medical subject headings
Neoplasms, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGA and geriatric follow-upOther

    The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up

Study groups in NCT02025062
Study groupRoleWhat they receive
ControlNo interventionIn the control arm, patients are followed-up by the head-and-neck physician, oncologist and radiotherapists and did not benefit of Comprehensive Geriatric Assessment.
Comprehensive Geriatric AssessmentExperimentalThe CGA (Comprehensive Geriatric Assessment) is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up.
Receives: Other: CGA and geriatric follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite criteria, including: death; autonomy (if loss of two points or more in the Activity of Daily Living (ADL) compared with the initial ADL); nutritional status (if weight loss of 10% or more compared to the initial weight at diagnosis

    Measured: 6 months after the randomization

Secondary outcomes (5)

  1. progression-free survival

    Measured: 6 month, 12 month and 24 month after the randomization

  2. death

    Measured: 6 month , 12 month and 24 month after the randomization

  3. total duration of hospitalization

    Measured: 6 month, 12 month and 24 month after the randomization

  4. quality of life (QLQC30, HN35)

    Measured: 6 month , 12 month and 24 month after the randomization

  5. costs of treatment

    Measured: 6 month , 12 month and 24 month after the randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionApr 2018
  4. Study completionSep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02025062
Sponsor's protocol ID
K120902
Other IDs
2013-A00437-38
Acronym
EGéSOR
Status last verified
Nov 2020
First submitted
21 Nov 2013
Last updated
23 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Abstracts of the 6th European Congress of Oto-Rhino-Laryngology Head and Neck Surgery, June 30-July 4, 2007, Vienna, Austria. Eur Arch Otorhinolaryngol. 2007 Jun;264 Suppl 1:S1-354. doi: 10.1007/s00405-007-0343-8. No abstract available.

    PubMed 17558509

  • Homma A, Sakashita T, Oridate N, Suzuki F, Suzuki S, Hatakeyama H, Mizumachi T, Taki S, Fukuda S. Importance of comorbidity in hypopharyngeal cancer. Head Neck. 2010 Feb;32(2):148-53. doi: 10.1002/hed.21158.

    PubMed 19536763

  • Lafont C, Paillaud E, Bertolus C, Baron M, Caillet P, Bouvard E, Laurent M, Salvan D, Chaumette L, de Decker L, Piot B, Barry B, Raynaud-Simon A, Sauvaget E, Minard A, Anota A, Panjo H, Brugel L, Canoui-Poitrine F. Geriatric assessment and quality of life for 2 years in older patients with head and neck cancer. J Natl Cancer Inst. 2024 May 8;116(5):758-763. doi: 10.1093/jnci/djae027.

    PubMed 38335935

  • Brugel L, Laurent M, Caillet P, Radenne A, Durand-Zaleski I, Martin M, Baron M, de Kermadec H, Bastuji-Garin S, Canoui-Poitrine F, Paillaud E. Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR). BMC Cancer. 2014 Jun 13;14:427. doi: 10.1186/1471-2407-14-427.

    PubMed 24923533

Questions about this trial

What is this clinical trial studying?

A study testing CGA and geriatric follow-up in people with Head and Neck Squamous Cell Carcinomas (HNSCCs), run by Assistance Publique - Hôpitaux de 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 23 Nov 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite criteria, including: death; autonomy (if loss of two points or more in the Activity of Daily Living (ADL) compared with the initial ADL); nutritional status (if weight loss of 10% or more compared to the initial weight at diagnosis (time frame: 6 months after the randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025062, which also lists 4 linked publications.

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 23 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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