TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer
Recruitment status was Recruiting
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.
Cavity of the Mouth Cancer
Drug: Taxotere, Cisplatin, 5-FU
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer|
- determination of progression-free survival after 2 years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- overall survival after 2 years [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
- Determination of the efficacy of the induction therapy [ Time Frame: after 1, 12 and 24 months ] [ Designated as safety issue: No ]CT or MRT of the neck region
- function of swallowing according the penetration-aspiration-scale [ Time Frame: 0,1, 6, 12, 18, 24 months ] [ Designated as safety issue: Yes ]assessed according the penetration-aspiration-scale (PAS, Rosenbek et al. 1996) and according measuring after Prosiegel (Prosiegel et al. 2002).
- Adverse events as a measure of safety and tolerability [ Time Frame: once a week ] [ Designated as safety issue: Yes ]The number of patients with adverse events will be evaluated. Adverse events will be assessed according CTCAE v.3.0 and analysed as number per patient and number per cycle.
- Quality of life [ Time Frame: 0,1, 6, 12, 18, 24 months ] [ Designated as safety issue: Yes ]EORTC QLQ-HN35 questionnaire filled in by the patients
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Infusion: Taxotere, Cisplatin, 5-FU
Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out.
Drug: Taxotere, Cisplatin, 5-FU
Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.
Other Name: Docetaxel
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.
|Städt. Kliniken Bielefeld gem. GmbH||Active, not recruiting|
|Bielefeld, Germany, 33604|
|Jena, Germany, 07740|
|Contact: Orlando Guntinas-Lichius, Prof. Dr. +49 (0)3641-935127 Orlando.Guntinas@med.uni-jena.de|
|Sub-Investigator: Claus Wittekindt, PD Dr. med.|
|Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde||Active, not recruiting|
|Leipzig, Germany, 04103|
|Klinikum Ernst von Bergmann||Active, not recruiting|
|Potsdam, Germany, 14467|
|Principal Investigator:||Orlando Guntinas-Lichius, Prof. Dr.||Friedrich-Schiller-University Jena|