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Metastatic or Recurrent Head and Neck Squamous Cell CancerPhase 2ELANFITNCT01864772

Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC

A Phase 2 study testing Carbo, 5FU, Cetuximab in people with Metastatic or Recurrent Head and Neck Squamous Cell Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 sites 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 aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment). Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Carbo, 5FU, Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
2 sitesFrance
Study dates
Sep 2013to 26 May 2020
Phase
Phase 2
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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age greater than or equal to 70 years
  • patient enrolled in ELAN-ONVOCAL study and evaluated as fit (harmonious aging) by GERICO screening method for geriatric frailty
  • life expectancy superior to 12 weeks
  • creatinin clearance > ou equal to 50ml/mn calculated using Modification of Diet in Renal Disease (MDRD) formula
  • hematologic function : absolute neutrophil count > 1.5 x 10^9/l, platelets > 100 x 10^9/l, hemoglobin > 9,5 g/dl
  • liver function : total bilirubin inferior to 1,25 x Upper limit of normal (ULN), SGOT/SGPT inferior to 5 x ULN, PAL inferior to 5 x ULN
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  • PS < 2
  • The disease:
  • histologically proven head and neck squamous cell carcinomas
  • recurrent or metastatic. Visceral metastases or locoregional recurrence unsuitable for curative locoregional treatment: unsuitable for primitive tumor surgery due to local extension (evidently authorized for lymph nodes) and unsuitable for radiotherapy for primitive tumor (or already performed) due to metastatic dissemination and the absence of indication for re-irradiation of primitive tumor.
  • Presence of at least one measurable lesion (defined by RECIST criteria) by CT scan or IRM
  • asymptomatic cerebral metastases authorized
  • General:
  • signed Informed Consent Form
  • affiliated to the French social security system (or a beneficiary of this system) according to the provisions of the law of 9 August 2004

Who cannot join

  • Previous systemic chemotherapy, except for chemotherapy as part of multimodal treatment for locally advanced cancer completed more than 6 months prior to study enrollment
  • Known contraindication specific to one of study treatments (particularly cardiac for 5FU)
  • Known dihydropyrimidine dehydrogenase deficiency (DPD deficiency).
  • Patients considered as "unfit " (fragile) by GERICO screening method for geriatric frailty
  • Irradiation within 4 weeks prior to study enrollment.
  • Nasopharyngeal, rhinopharyngeal or maxillary sinus carcinoma.
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  • Presence of infection (infection requiring intravenous antibiotics), including tuberculosis and HIV infection (human immunodeficiency virus).
  • Concomitant treatment with other antitumor immunotherapy or hormonal therapy.
  • Other antitumor concomitant therapies.
  • Prior treatment with EGFR-targeted therapy (epidermal growth factor receptor).
  • Treatment with one of study drugs within 30 days prior to study enrollment.
  • Presence of documented symptomatic brain or leptomeningeal metastases
  • Clinically significant coronaropathy or antecedent myocardial infarction within 12 months prior to study enrollment or high-risk uncontrolled arrhythmias or uncontrolled heart failure.
  • Medically uncontrolled arterial hypertension
  • Other prior or concomitant cancer, with exception for carcinoma in situ of the uterine cervix, or for cutaneous basal cell carcinoma within 5 years prior to study enrollment.
  • Presence of medical or physiological factors susceptible to modify patient compliance with study protocol and follow-up or Informed Consent Form signing.
  • Known allergy or hypersensibility to monoclonal antibodies (bevacizumab, cetuximab), or to other chemotherapies of the study or to their excipients

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital de la Dracénie

    Draguignan, 83300

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

Being tested
Carbo, 5FU, Cetuximab
Keywords
HNSCC, Metastatic, Recurrent, Elderly, Geriatry
Medical subject headings
Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck, Recurrence

What participants receive

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

  • Carbo, 5FU, CetuximabDrug

    6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w)

    Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity

Study groups in NCT01864772
Study groupRoleWhat they receive
Carbo, 5FU, CetuximabExperimental6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity
Receives: Drug: Carbo, 5FU, Cetuximab

What is being measured

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

  1. Objective response and acute toxicity

    Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy

    Measured: 1 month after the end of chemotherapy

Secondary outcomes (7)

  1. Best objective tumor response

    Best objective tumor response during treatment

    Measured: 6 weeks after the end of treatment

  2. Overall survival

    Overall survival

    Measured: 1 year after the end of treatment

  3. progression free survival

    progression free survival

    Measured: 1 year after the end of treatment

  4. Duration of response under cetuximab maintenance therapy

    Duration of response under cetuximab maintenance therapy

    Measured: 1 year after the end of maintenance

  5. Toxicity of cetuximab maintenance therapy

    Toxicity of cetuximab maintenance therapy

    Measured: 3 months after the end of maintenance

  6. autonomy

    Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment

    Measured: 1 month after the end of treatment

  7. Health related quality of life

    Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires

    Measured: 1 month after the end of chemotherapy

Timeline

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

  1. First posted30 May 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionApr 2020
  4. Study completion26 May 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864772
Sponsor's protocol ID
GORTEC ELAN-FIT
Acronym
ELANFIT
Status last verified
Aug 2022
First submitted
21 May 2013
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Guigay J, Le Caer H, Ferrand FR, Geoffrois L, Saada-Bouzid E, Fayette J, Sire C, Cupissol D, Blot E, Guillet P, Pavillet J, Bozec L, Capitain O, Rolland F, Debourdeau P, Pointreau Y, Falandry C, Lopez S, Coutte A, Chatellier T, Dalloz P, Ortholan C, Michel C, Lacas B, Cheurfa N, Schwob D, Bourhis J, Mertens C, Auperin A; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups, and GORTEC. Adapted EXTREME regimen in the first-line treatment of fit, older patients with recurrent or metastatic head and neck squamous cell carcinoma (ELAN-FIT): a multicentre, single-arm, phase 2 trial. Lancet Healthy Longev. 2024 Jun;5(6):e392-e405. doi: 10.1016/S2666-7568(24)00048-5. Epub 2024 May 14.

    PubMed 38759667

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carbo, 5FU, Cetuximab in people with Metastatic or Recurrent Head and Neck Squamous Cell Cancer, run by Groupe Oncologie Radiotherapie Tete et Cou at 2 sites 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 15 inclusion and 17 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Objective response and acute toxicity (time frame: 1 month after the end of chemotherapy). 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 NCT01864772, which also lists 1 linked publication.

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 19 Aug 2022.

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