60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients. Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer. Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Erlotinib 150 mg, p.o., once daily
Vinorelbine 25 mg/m2, i.v., day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v., day 1 of every cycle
Gemeinschaftspraxis
Augsburg, Germany
RECRUITINGZentralklinik Bad Berka GmbH
Bad Berka, Germany
RECRUITINGCharité - Campus Benjamin Franklin
Berlin, Germany
RECRUITINGHelios Klinikum Emil von Behring
Berlin, Germany
Evaluation of the progression free survival rate with the first-line therapy
Time frame: Tumour assessment every other cycle (interval of 42 days)
Duration of remission
Time frame: Tumour assessment every other cycle (interval of 42 days)
1-year survival
Time frame: 1 year
Overall survival
Time frame: End of study
Response rate (CR/RR)
Time frame: Tumour assessment every other cycle (interval of 42 days)
Quality of life, improvement of symptoms (FACT-L)
Time frame: Every other cycle (interval of 42 days)
Simplified Charlsons´Comorbidity Score
Time frame: baseline
Safety and Tolerability
Time frame: continously
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Evangelische Lungenklinik Berlin
Berlin, Germany
RECRUITINGEvang. Krankenhaus Bielefeld
Bielefeld, Germany
RECRUITINGJohanniter-Krankenhaus Bonn
Bonn, Germany
RECRUITINGGemeinschaftspraxis
Celle, Germany
RECRUITINGMalteser Krankenhaus St. Hildegardis Köln
Cologne, Germany
RECRUITINGFachkrankenhaus Coswig
Coswig, Germany
RECRUITING...and 30 more locations