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.

NCT02109549 | Completed

• 1 other identifier: Metformin NSCLC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Assessment of metformin use

  Assessment of metformin use (in patients with diabetes mellitus) on overall survival in advanced stage NSCLC patients undergoing radiochemotherapy.

  2 years after radiotherapy

• Assessment of insulin use

  Assessment of insulin use (in patients with diabetes mellitus) on overall survival in advanced stage NSCLC patients undergoing radiochemotherapy.

  2 years after radiotherapy

Secondary Outcomes (1)

• Overall assessment of overall survival and toxicity factors

  2 years after radiotherapy

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced stage non-small cell lung cancer

You may qualify if:

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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastro Clinic, The Netherlands: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (3)

The Netherlands Cancer Institute (NKI)

Amsterdam, 1066 CX, Netherlands

Location

AMC

Amsterdam, 1105 AZ, Netherlands

Location

MAASTRO clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philippe Lambin, MD, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

• Esther Troost

  Maastro Clinic, The Netherlands

  STUDY CHAIR

• José Belderbos

  NKI Amsterdam

  PRINCIPAL INVESTIGATOR

• Edith Dieleman

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

NL (3)