A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1)

Annals of Oncology : Official Journal of the European Society for Medical Oncology
Johanna InhesternOrlando Guntinas-Lichius

Abstract

Induction chemotherapy (ICT) with docetaxel, cisplatin and fluorouracil (TPF) followed by radiotherapy is an effective treatment option for locally advanced head and neck cancer. This phase II study investigated the effectivity of a split-dose TPF ICT before surgery for locally advanced resectable (stage III/IVA) oral and oropharyngeal cancer. Patients received TPF split on two dosages on days 1 and 8 per cycle (30 mg/m2 docetaxel, 40 mg/m2 cisplatin, 2000 mg/m2 fluorouracil per week). Responders (reduction tumor volume ≥30% after first cycle) received three 3-week cycles and non-responders only one cycle before surgery and postoperative radio(chemo)therapy (RCT). The primary endpoint was progression-free survival rate after 24 months. Secondary endpoints were amongst others overall survival, histopathological response to ICT, toxicity, quality of life and swallowing function. Fifty-four patients (91% stage IVA, 87% male, 72% oropharyngeal cancer, 70% responders) were eligible for a per-protocol analysis. The progression-free survival rate after 24 months was 88.5% for responders and 60.6% for non-responders (P = 0.005). The overall survival rate after 24 months was 97.3% for responders and 73.7% for non-responders (P = 0.032)....Continue Reading

Associated Clinical Trials

Apr 21, 2010·Orlando Guntinas-Lichius, Prof. Dr. med.

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Citations

Jan 30, 2020·Cancer Science·Wu-Tong JuLai-Ping Zhong
Jul 28, 2019·Oral Oncology·Max GauJérôme Fayette
May 26, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M T JacobsE E Cohen
Oct 7, 2021·Laryngo- rhino- otologie·Andreas DietzSusanne Wiegand
Dec 21, 2021·The Cochrane Database of Systematic Reviews·Ambika ParmarKelvin Kw Chan

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