Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determination of progression-free survival after 2 years
Orlando Guntinas-Lichius, Prof. Dr.
Germany: Federal Institute for Drugs and Medical Devices