Radio-Chemo-Therapie - clinical part

RCT (clinical part): In this prospective phase II-trial patients received concurrent rct with Gemcitabin 75 mg/m2 once weekly as radiosensitizer simultaneous to conventional fractionated rt. Study was planed in addition to simons optimal plan for phase II-trials and the primary endpoint was overall response. There were 10 female and 62 male with median age of 58 years. All patients had scc in advanced stage of disease (95% stadium IV, 76% T4, 82% nodal positive) of the oral cavity or the adjunctive oropharynx. All patients were available for toxicity and 61 patients were available for response, survival and time to progression. Overall response rate was 89%, in 74% a CR and in 15% a PR was seen as best result. Median survival was 32 month with 77% of all patients alive after one year and 56% after 2 years. Time to progression was median 2,6 years and after 3 years 51% of all patients was without recurrent disease. Low dose gemcitabin is in this setting a potent radiosensitizing agent with favourable toxicity profile. Prolongation until 04/2007.
Head of Project:

Dr. Jan-Dirk Raguse
Charité - Universitätsmedizin Berlin
Department of Oral and Maxillofacial Surgery (including ENT) CVK
Tel. 450-555173
Fax 450-555901
Additional Head of Project:

Prof.Dr. Jürgen Bier
Additional Member of Project:

Birgit Milluks
Begin/End of Project:

04/2003- 09/2005
Funded by:

ohne Fördergeber

Phase II trial of radiation concurrent with Gem for unresectable scchn. Raguse JD et al. Onkologie 2003, 26(S5): 36