Oropharynx Cancer Clinical Trial
Official title:
Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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