Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.
Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines. Secondary objective is * To evaluate pathological response determined by histological work up of the surgical specimens according to TNM stages. * To evaluate the metabolic response determined by PET analysis. * To assess overall survival (OS) (median survival time and percentage of 1-year survival). OS is defined as time elapsed from the date of patient inclusion until recorded date of death. * To characterize and quantify toxic effects of the scheduled therapy. Safety profile and tolerability will be assessed by recording adverse events, clinically significant laboratory abnormalities, physical examination and vital signs. Toxicities will be evaluated according to the NCI-CTC Toxicity Criteria and adverse events which are not reported in NCI-CTC will be graded as mild, moderate, severe or life-threatening. All patients who received any of the scheduled therapy will be included in the overall toxicity analysis. * To evaluate the immunological response determined by regulatory T-cells and immune activation markers, to define chemoresistance by pharmacogenomic testing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
75mg/m², day 1,22
40mg/m², d1,2,22,23
400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)
University Hospital, Internal Medicine
Innsbruck, Tyrol, Austria
Hosptial Kufstein
Kufstein, Tyrol, Austria
Hospital Natters
Natters, Tyrol, Austria
Hospital Zams
Zams, Tyrol, Austria
overall response rate (complete plus partial response) according to RECIST guidelines
Time frame: June 2011
Pathological response
Time frame: June 2011
Metabolic response
Time frame: June 2011
Immunological response
Time frame: June 2011
Overall survival
Time frame: June 2011
Safety profile and tolerability
Time frame: June 2011
overall response rate (complete plus partial response) according to RECIST guidelines
Time frame: June 2011
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28 days after end of induction chemotherapy
Prim. Dr. Bolitschek
Linz, Austria
Prim. Dr. H. Schinko
Linz, Austria
OA Dr. Rainer Kolb
Wels, Austria