ELAN-UNFIT
Multicentric Randomized Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer in Elderly Unfit Patients According to Geriatric Evaluation
Sponsor study identifier
Secondary identifiers
OTHER · CSET number
interventional
82
1 country
1
Study Start
November 6, 2013
Actual (reported)Primary Completion
October 12, 2021
Actual (reported)Study Completion
October 12, 2021
Actual (reported)To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC. Efficacy assessed by failure free survival
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2013
Actual (reported)June 24, 2013
Actual (reported)November 6, 2013
Actual (reported)October 12, 2021
Actual (reported)October 12, 2021
Actual (reported)Failure free survival (FFS)
Composite criteria of efficacy and tolerance: Failure free survival (FFS) defined as time from randomization to the first event among progression (defined by RECIST criteria), treatment stop (whatever the cause), loss of 2 points or more in Activities in Daily Living (ADL) scale and death (whatever the cause). Patients who don't have any of these events are censored at the date of last follow-up.
From randomization to the first event among progression, treatment stop, whatever the cause, loss of 2 points or more in ADL scale and death assessed up to 16 months
Overall survival (OS)
From randomization to death from any cause assessed up to 1 months
Progression free survival (PFS)
From randomization to progression assessed up to 16 months
Dosing schedule: 500 mg/m², every two weeks (q2w) Mode of administration: IV
Dosing schedule: 40mg/m2 weekly (q1w) Mode of administration: IV
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institut Gustave Roussy
Villejuif, Val De Marne, 94805, France
Guigay J, Ortholan C, Vansteene D, Cupissol D, Even C, Kaminsky MC, Sire C, Blot E, Debourdeau P, Bozec L, Saada-Bouzid E, Fayette J, Dalloz P, Pointreau Y, Caer HL, Falandry C, Digue L, Braccini A, Lopez S, Guillet P, Michel C, Cheurfa N, Schwob D, Bourhis J, Mertens C, Auperin A; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups and the GORTEC. Cetuximab versus methotrexate in first-line treatment of older, frail patients with inoperable recurrent or metastatic head and neck cancer (ELAN UNFIT): a randomised, open-label, phase 3 trial. Lancet Healthy Longev. 2024 Mar;5(3):e182-e193. doi: 10.1016/S2666-7568(23)00284-2.
Joel GUIGAY, Pr
Gustave Roussy, Cancer Campus, Grand Paris
82 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2013
First Posted
June 24, 2013
Study Start
November 6, 2013
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
October 12, 2021
Actual (reported)Study Completion
October 12, 2021
Actual (reported)Last Updated
February 9, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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