Non Small Cell Lung CancerMetforminNCT02109549
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.
An observational study of Non Small Cell Lung Cancer, run by Maastricht Radiation Oncology at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 70 participants
- Where
- 3 sitesNetherlands
- Study dates
- Mar 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced stage non-small cell lung cancer
Who may be able to join
- Advanced non-small cell lung cancer patients undergoing primary concurrent radiochemotherapy; patients treated with metformin or insulin will be analyzed as separate cohorts.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
The Netherlands Cancer Institute (NKI)
Amsterdam, 1066 CX
AMC
Amsterdam, 1105 AZ
MAASTRO clinic
Maastricht, 6229 ET
About this study
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of metformin use
Assessment of metformin use (in patients with diabetes mellitus) on overall survival in advanced stage NSCLC patients undergoing radiochemotherapy.
Measured: 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.
Measured: 2 years after radiotherapy
Secondary outcomes (1)
Overall assessment of overall survival and toxicity factors
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
Measured: 2 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastro Clinic, The Netherlands, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Sponsor
- Investigators
- Philippe Lambin, MD, PhD, Principal investigator, Maastro Clinic, The NetherlandsEsther Troost, Study chair, Maastro Clinic, The NetherlandsJosé Belderbos, Principal investigator, NKI AmsterdamEdith Dieleman, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109549
- Sponsor's protocol ID
- Metformin NSCLC
- Acronym
- Metformin
- Status last verified
- May 2016
- First submitted
- 26 Mar 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Metformin Use on Treatment Outcome in NSCLC Patients
- ClinicalTrials.gov ID
- NCT02109549
- Acronym / sponsor ID
- Metformin / Metformin NSCLC
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastro Clinic, The Netherlands, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced stage non-small cell lung cancer
Key inclusion criteria (1 listed)
- Advanced non-small cell lung cancer patients undergoing primary concurrent radiochemotherapy; patients treated with metformin or insulin will be analyzed as separate cohorts.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Overall assessment of overall survival and toxicity factors
Time frame: 2 years after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Lambin, MD, PhD principal investigator
Maastro Clinic, The Netherlands
Esther Troost study chair
Maastro Clinic, The Netherlands
José Belderbos principal investigator
NKI Amsterdam
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Maastricht Radiation Oncology at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of metformin use (time frame: 2 years after radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.