The DeLOS II trial is a multicenter randomised phase II trial investigating a TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Radiation start in week 11
Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
75 mg/m2 i.v. day 1 3 times
75 mg/m2 i.v. day 1 3 times
Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
Universitätsklinik für HNO
Graz, Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Helios Klinikum Erfurt GmbH Klinik für HNO-Heilkunde, Plastische Operationen
Erfurt, Thuringia, Germany
Universitätsklinik Aachen
Aachen, Germany
Charité, Campus Benjamin Franklin
Berlin, Germany
Klinikum Neukölln, Vivantes GmbH
Berlin, Germany
Klinikum Bielefeld-Mitte
Bielefeld, Germany
Universitätsklinik Köln
Cologne, Germany
Malteser Krankenhaus St. Anna gGmbH, HNO-Klinik
Duisburg, Germany
...and 17 more locations
Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation
Time frame: LFS-rate 2 years after randomisation
Descriptive analysis of the study arms concerning the secondary end criteria of the study
Time frame: LSF 2 years after randomisation
Explorative comparison of the study arms concerning the primary and secondary end criteria of the study
Time frame: LSF 2 years after randomisation
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