Non Small Cell Lung Cancer Clinical Trial
Official title:
Influence of Metformin Use on Treatment Outcome in NSCLC Patients
There are preliminary data suggesting that patients suffering from non-insulin-dependent
diabetes mellitus, treated with metformin, have improved local tumor control. A reduction in
the tumor's hypoxia may be responsible for this phenomenon.
Therefore, the aim of this study is to test the hypothesis in three cohorts of patients
suffering from advanced stage non-small cell lung cancer and all undergoing concurrent
radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin only; 2.
Patients with insulin-dependent diabetes mellitus not treated with metformin; 3. The
remaining patients serving as controls. Furthermore, tumor and treatment-related parameters
will be correlated with overall survival and morbidity.
There are preliminary clinical and preclinical data suggesting that patients suffering from
non-insulin-dependent diabetes mellitus, treated with metformin, have improved local tumor
control. The reduction in oxygen consumption of tumor cells and thus a relative reduction in
the tumor's hypoxia may be responsible for this.
Non-small cell lung cancer is the most frequent solid tumor in many Western countries and
the number one cause of cancer-related death. Even though the introduction of concurrent
chemoradiotherapy has improved local tumor control and thus overall survival, 5-year overall
survival is still as low as 14%. Furthermore, many patients are not eligible to undergo
concurrent treatment thus reducing their chances to defeat this disease. Additionally,
concurrent chemoradiotherapy is associated with increased toxicity compared to sequential
treatment. Therefore, alternative additives improving the effect of radiotherapy without
increasing toxicity to an unbearable level are searched for. One possible pharmaceutical is
metformin; many patients have been using it in the past without evident increased toxicity,
it is cheap, and widely available.
Thus, the aim of this study is to test the hypothesis that metformin increases overall
survival without enhancing treatment-related toxicity. For this means, in three cohorts of
patients suffering from advanced stage non-small cell lung cancer and all undergoing
concurrent radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin
only; 2. Patients with insulin-dependent diabetes mellitus not treated with metformin; 3.
The remaining patients serving as controls. Using Kaplan-Meier statistics as well as uni-
and multivariate analysis, the overall survival and toxicity of these cohorts will be
compared. Other potentially confounding factors will be tested as secondary endpoints.
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Observational Model: Cohort, Time Perspective: Retrospective
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