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

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).

Timeline

Start

2013-09

Primary completion

2020-04

Completion

2020-05-26

Outcome

Met primary endpoint

paper The study met its primary objectives on objective response and morbidity PMID 38759667 ↗

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.

Drugs

Indications