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Non Small Cell Lung Cancer | Influence of the Use of the Diabetic Drug Metformin on the Overall Survival and Treatment-related Toxicity in Advanced Stage Non-small Cell Lung Cancer Patients.

Non Small Cell Lung Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: Advanced non-small cell lung cancer patients undergoing primary concurrent radiochemotherapy; patients treated with metformin or insulin will be analyzed as separate cohorts.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Non Small Cell Lung Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Diabetes and metforminPatients with diabetes mellitus treated with metformin only.

Insulin-diabetes without metforminPatients with insulin-dependent diabetes mellitus not treated with metformin

ControlgroupThe remaining patients serve as control group.

Study Status

Completed

Start Date: March 2014

Completed Date: February 2016

Phase:

Type: Observational

Design:

Primary Outcome: Assessment of metformin use

Secondary Outcome: Overall assessment of overall survival and toxicity factors

Study sponsors, principal investigator, and references

Principal Investigator: Philippe Lambin, MD, PhD

Lead Sponsor: Maastricht Radiation Oncology

Collaborator: Maastro Clinic, The Netherlands

More information:https://clinicaltrials.gov/show/NCT02109549

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