{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"TPExtreme","nct_id":"NCT02268695","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tpextreme-nct02268695. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TPExtreme","arms":[{"description":"Chemotherapy: 6 cycles (every 3 weeks) of Cisplatin (100 mg/m² iv on Day1), 5FU (4000 mg/m² total dose starting on day 1 and during 96h in continuous infusion), and Cetuximab (loading dose of 400 mg/m² iv on Day1, then 250 mg/m² iv weekly).\n\nIf cisplatin is not tolerated and/or when the total cumulative dose of cisplatin (including prior administration) reaches 600 mg/m², cisplatin has to be replaced by carboplatin, AUC 5 (but not exceeding 750 mg), except in the case of bleeding tumor.\n\nCetuximab maintenance : cetuximab continuation (250 mg/m² iv weekly) will begin only if at least disease stabilization is observed at the end of chemotherapy, and will be continued until PD or unacceptable toxicity.","label":"EXTREME: Cisplatin, 5-FU and Cetuximab","type":"ACTIVE_COMPARATOR"},{"description":"Chemotherapy: 4 cycles (every 3 weeks) of Cisplatin (75 mg/m² iv on Day1), Docetaxel (75 mg/m² iv on Day1), and Cetuximab (loading dose of 400 mg/m² iv on Day1, then 250 mg/m² iv weekly).\n\nIf Cisplatin is not tolerated, cisplatin is replaced by carboplatin, AUC 5 (but not exceeding 750 mg), except in the case of bleeding tumor.\n\nPrimary prophylactic administration of GCSF must be administered systematically after each cycle of chemotherapy.\n\nCetuximab maintenance : cetuximab continuation (500 mg/m² iv every two weeks) will begin only if at least disease stabilization is observed at the end of chemotherapy, and will be continued until PD or unacceptable toxicity.","label":"TPEx: Cisplatin, Docetaxel and Cetuximab","type":"EXPERIMENTAL"}],"collaborators":["Grupo Español de Tratamiento de Tumores de Cabeza y Cuello","AIO-Studien-gGmbH"],"completion_date":{"date":"2021-12-31","type":"ACTUAL"},"conditions":["Head and Neck Squamous Cell Carcinoma"],"enrollment":{"count":541,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"5-Fluorouracile","otherNames":[],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"},{"name":"Cetuximab","otherNames":[],"type":"DRUG"},{"name":"granulocyte colony-stimulating factor (G-CSF)","otherNames":[],"type":"DRUG"}],"last_update":"2022-08-23","lead_sponsor":"Groupe Oncologie Radiotherapie Tete et Cou","official_title":"TPExtreme: Randomized, Controlled Trial of Platinum-Cetuximab Combined Either With Docetaxel (TPEx) or With 5FU (Extreme) in Patients With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-12-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall survival","timeFrame":"Until patient death or at least one year after the end of the treatment"}],"references":[{"citation":"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.","pmid":"40848743","type":"DERIVED"},{"citation":"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.","pmid":"39722558","type":"DERIVED"},{"citation":"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.","pmid":"33684370","type":"DERIVED"}],"start_date":{"date":"2014-10-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC","url":"https://clinicaltrials.gov/study/NCT02268695"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tpextreme-nct02268695"}