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Brief Title: TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer
Official Title: Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
Study ID: NCT01108042
Brief Summary: A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks. In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined. In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.
Detailed Description: Local advanced Oropharyngeal and cavity of the mouth Cancer are often treated with a combination of surgery and/or radiation and /or chemotherapy. Despite of therapy improvement there are only little advances in progression-free survival and overall survival. Therefore new therapy concepts are needed. The advantage of the induction chemotherapy is the possibility of tumor response assessment during chemotherapy and may present a selection criterion for organ preservation. In order to minimize the time between chemotherapy and surgery it is important to have an early answer for the tumor response. In this study response will be assessed after the first cycle of chemotherapy. Patients showing no tumor response will be operated at once. The other patients will receive further cycles of chemotherapy. Toxicity of the induction chemotherapy have to be moderate because surgery should not be delayed. To improve the tolerance of induction therapy the medication dose isn't given on day 1 every 3 weeks, but is dispersed on day 1 and day 8, q3weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Städt. Kliniken Bielefeld gem. GmbH, Bielefeld, , Germany
Friedrich-Schiller-University Jena, Jena, , Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde, Leipzig, , Germany
Klinikum Ernst von Bergmann, Potsdam, , Germany
Name: Orlando Guntinas-Lichius, Prof. Dr.
Affiliation: Friedrich-Schiller-University Jena
Role: PRINCIPAL_INVESTIGATOR