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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. (Metformin)

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ClinicalTrials.gov Identifier: NCT02109549
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : June 1, 2016
Sponsor:
Collaborators:
Maastro Clinic, The Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:

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.


Condition or disease
Non Small Cell Lung Cancer

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Influence of Metformin Use on Treatment Outcome in NSCLC Patients
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
Diabetes and metformin
Patients with diabetes mellitus treated with metformin only.
Insulin-diabetes without metformin
Patients with insulin-dependent diabetes mellitus not treated with metformin
Controlgroup
The remaining patients serve as control group.



Primary Outcome Measures :
  1. Assessment of metformin use [ Time Frame: 2 years after radiotherapy ]
    Assessment of metformin use (in patients with diabetes mellitus) on overall survival in advanced stage NSCLC patients undergoing radiochemotherapy.

  2. Assessment of insulin use [ Time Frame: 2 years after radiotherapy ]
    Assessment of insulin use (in patients with diabetes mellitus) on overall survival in advanced stage NSCLC patients undergoing radiochemotherapy.


Secondary Outcome Measures :
  1. Overall assessment of overall survival and toxicity factors [ Time Frame: 2 years after radiotherapy ]

    Composite outcome measure:

    Assessment of factors influencing overall survival and toxicity:

    Age Gender Performance status WHO TNM stage Histology Delivered radiation dose Total gross tumor volume Total planning target volume




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced stage non-small cell lung cancer
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109549


Locations
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Netherlands
The Netherlands Cancer Institute (NKI)
Amsterdam, Netherlands, 1066 CX
AMC
Amsterdam, Netherlands, 1105 AZ
MAASTRO clinic
Maastricht, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastro Clinic, The Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Philippe Lambin, MD, PhD Maastro Clinic, The Netherlands
Study Chair: Esther Troost Maastro Clinic, The Netherlands
Principal Investigator: José Belderbos NKI Amsterdam
Principal Investigator: Edith Dieleman Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02109549     History of Changes
Other Study ID Numbers: Metformin NSCLC
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Lung Diseases
Metformin
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Hypoglycemic Agents
Physiological Effects of Drugs