TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer
|ClinicalTrials.gov Identifier: NCT01108042|
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : May 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Oropharynx Cancer Squamous Cell Carcinoma of the Oral Cavity||Drug: Taxotere, Cisplatin, 5-Fluorouracil (5-FU)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer|
|Study Start Date :||November 2009|
|Primary Completion Date :||January 2016|
|Study Completion Date :||February 2016|
Experimental: Taxotere, Cisplatin, 5-Fluorouracil (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-Fluorouracil (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
- Determination of progression-free survival after 2 years [ Time Frame: 24 months ]
- Overall survival after 2 years [ Time Frame: after 2 years ]
- Determination of the efficacy of the induction therapy [ Time Frame: after 1, 12 and 24 months ]CT or magnetic resonance tomography (MRT) of the neck region
- Function of swallowing according the penetration-aspiration-scale [ Time Frame: 0,1, 6, 12, 18, 24 months ]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 ]The number of patients with adverse events will be evaluated. Adverse events will be assessed according Common Terminology Criteria of Adverse Events (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 ]European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ) for head and neck cancer patients (HN35) questionnaire filled in by the patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108042
|Städt. Kliniken Bielefeld gem. GmbH|
|Bielefeld, Germany, 33604|
|Jena, Germany, 07740|
|Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde|
|Leipzig, Germany, 04103|
|Klinikum Ernst von Bergmann|
|Potsdam, Germany, 14467|
|Principal Investigator:||Orlando Guntinas-Lichius, Prof. Dr.||Friedrich-Schiller-University Jena|