Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC

Summary

This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

Timeline

Start

2014-10-10

Primary completion

2021-12-31

Completion

2021-12-31

Publications

• Fraslin AM, Auperin A, Even C, Fayette J, Saada-Bouzid E, Lafond C, Geoffrois L; TPExtreme-ECO Group; Bourhis J, Guigay J, Bonastre J. Cost-Utility Analysis Alongside the GORTEC 2014-01 TPExtreme Trial: TPEx Versus EXTREME as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Value Health. 2025 Dec;28(12):1793-1801. doi: 10.1016/j.jval.2025.07.032. Epub 2025 Aug 21.
• Atsou K, Auperin A, Guigay J, Salas S, Benzekry S. Mechanistic Learning for Predicting Survival Outcomes in Head and Neck Squamous Cell Carcinoma. CPT Pharmacometrics Syst Pharmacol. 2025 Mar;14(3):540-550. doi: 10.1002/psp4.13294. Epub 2024 Dec 25.
• Guigay J, Auperin A, Fayette J, Saada-Bouzid E, Lafond C, Taberna M, Geoffrois L, Martin L, Capitain O, Cupissol D, Castanie H, Vansteene D, Schafhausen P, Johnson A, Even C, Sire C, Duplomb S, Evrard C, Delord JP, Laguerre B, Zanetta S, Chevassus-Clement C, Fraslin A, Louat F, Sinigaglia L, Keilholz U, Bourhis J, Mesia R; GORTEC; AIO; TTCC, and UniCancer Head and Neck groups. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2021 Apr;22(4):463-475. doi: 10.1016/S1470-2045(20)30755-5. Epub 2021 Mar 5.

Drugs

Indications