{"entity":{"id":"tpextreme","kind":"trial","name":"TPExtreme (GORTEC 2014-01)","aka":["TPExtreme","GORTEC 2014-01"],"tldr":"TPExtreme compared a shorter, docetaxel-based version of the standard EXTREME chemotherapy for advanced head and neck cancer with the original; patients lived about as long on either, and the shorter regimen was easier to tolerate, so it became an accepted alternative.","summary":"The EXTREME regimen of platinum, fluorouracil and cetuximab was the first-line standard for recurrent or metastatic head and neck squamous cell carcinoma for a decade but requires six cycles of infusional fluorouracil. TPExtreme, a French randomised phase 2 trial of 541 patients, compared TPEx (docetaxel, cisplatin and cetuximab for four cycles with G-CSF support) against EXTREME, both followed by cetuximab maintenance. The primary endpoint was overall survival.\n\nOverall survival was not superior with TPEx, so the primary endpoint was not met, but survival was similar, the regimen was shorter, and it caused fewer severe adverse events. TPEx is now an accepted first-line chemotherapy backbone, in particular for patients with rapidly progressing disease or after immunotherapy, since pembrolizumab-based regimens displaced EXTREME in first line after KEYNOTE-048.","status":"mixed","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02268695","url":"https://clinicaltrials.gov/study/NCT02268695"}],"tags":["subtype-trials"],"related":[],"cancers":["recurrent-metastatic-hnscc","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":["docetaxel","cisplatin","cetuximab","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["joel-guigay"],"bottlenecks":[],"keyPapers":["paper-tpextreme-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02268695","phase":"2","setting":"Untreated recurrent or metastatic head and neck squamous cell carcinoma: the TPEx regimen (docetaxel, cisplatin and cetuximab, four cycles) against the EXTREME regimen (fluorouracil, cisplatin and cetuximab, six cycles), each followed by cetuximab maintenance","sponsor":"GORTEC (Groupe Oncologie Radiotherapie Tete et Cou)","result":"TPEx did not improve overall survival over EXTREME, but gave similar survival with a shorter schedule and less toxicity.","yearReported":2021,"enrolled":541,"outcomes":[]},"route":"/trials/tpextreme/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"drug":[{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"}],"person":[{"id":"joel-guigay","kind":"person","name":"Joël Guigay","route":"/people/joel-guigay/"}],"paper":[{"id":"paper-tpextreme-lancet-oncol-2021","kind":"paper","name":"TPExtreme (GORTEC 2014-01): docetaxel, cisplatin and cetuximab versus the EXTREME regimen in recurrent or metastatic head and neck cancer","route":"/key-papers/paper-tpextreme-lancet-oncol-2021/"}]}}