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Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy (ALMERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02115464
Recruitment Status : Active, not recruiting
First Posted : April 16, 2014
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief Summary:
ALMERA is a randomized, phase II, open label study in patients with locally advanced non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent chemotherapy with or without consolidation versus the same treatment plus concurrent Metformin continuing for 12 months. Metformin is a well tolerated and inexpensive drug that has the potential to improve cancer patient outcomes.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Metformin plus Chemo-radiotherapy Radiation: Chemo-radiotherapy Phase 2

Detailed Description:

This is a randomized, phase II, open label study in patients with locally advanced NSCLC which will compare standard RT (60-63 Gy for 6 weeks) plus concurrent Cisplatin-based chemotherapy (CRT) with or without consolidation (standard arm) vs the same CRT with or without consolidation plus treatment with Metformin concurrent with CRT and continuing for a total of 12 months (experimental arm). Ninety-four eligible and consenting patients will be randomized to one of the two treatment arms. Patients randomized to the experimental arm will receive Metformin (2000 mg/day) for a period of 12 months. Patients will be continuously evaluated for toxicity, will be assessed weekly at clinic visits during concurrent CRT treatment with or without consolidation and at follow up clinic visits at 3, 6, 9 and 12 months (from the date of randomization). Disease progression will be evaluated every 3 months for up to 12 months. All patients will be followed for up to 24 months (2 years) for survival.

The primary objective of this study is to determine the effect of Metformin on the proportion of patients free of disease progression at 12 months after initiation of drug treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Investigate a Combination of Metformin With Chemo-Radiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : December 17, 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Metformin plus Chemo-radiotherapy
Metformin orally 500 mg twice daily for the first week, 1500 mg a day in week 2 and 2000 mg a day at week 3 and then for a period of 12 months. Cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
Drug: Metformin plus Chemo-radiotherapy
Metformin 2000 mg a day for 12 months plus cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
Other Name: Metformin Hydrochloride

Active Comparator: Chemo-radiotherapy
Concurrent cisplatin based chemotherapy with or without consolidation and radiotherapy of 60-63 Gy for 6 weeks.
Radiation: Chemo-radiotherapy
Cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]
    Progression free survival illustrates loco-regional disease control and freedom from distant metastasis


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 18-24 months ]
    Overall survival will be defined from the date of randomization until the date of death due to any cause.

  2. Time to loco-regional progression [ Time Frame: 18-24 months ]
    Time to loco-regional progression is defined from the date of randomization until the date of confirmed loco-regional progression

  3. Distant progression-free survival [ Time Frame: 18-24 months ]
    Distant progression-free survival is defined from the date of randomization until the date of distant progression, or death due to any cause.

  4. Toxicities [ Time Frame: 12 months plus 30 days ]
    The adverse event reporting period begins from the time of randomization and ends 30 days after the last treatment (concurrent chemo-radiotherapy plus or minus Metformin). Only adverse events assessed as Grade 3 or higher will be documented.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >/=18 to </= 80 years of age.
  2. Unresected and pathologically (histologic) proven Stage 3a or Stage 3b NSCLC of adenocarcinoma, squamous cell, large cell or mixed histology, diagnosed within three months of study randomization.
  3. Non-metastatic disease staged by: CT-chest and upper abdomen, brain MRI or contrast-enhanced CT within 12 weeks and physical examination and whole body FDG-PET/CT scan within 8 weeks prior to study randomization.

Exclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status >2.
  2. More than 10% weight loss in the past 3 months.
  3. Diabetic patient or anyone currently taking Metformin, insulin or other anti-hyperglycemic therapy.
  4. Pulmonary Function Test (PFTs) (within the last 12 weeks) with Forced Expiratory Volume (FEV)1 < 1.2 litres per second or less than 50% of predicted.
  5. Complete Blood Count (CBC) and biochemical renal and liver function profiles that do not permit chemotherapy treatment (as per institutional standard of care).
  6. Fasting blood sugar levels of >/= 7.0 mmol per litre (within the last 12 weeks).
  7. Prior systemic chemotherapy for lung cancer.
  8. Prior radiotherapy that would overlap with the planned treatment area.
  9. Prior invasive malignancy within the past 3 years (except non-melanomatous skin cancer non-invasive carcinoma in-situ of the breast, oral cavity or cervix).
  10. Known Acquired Immune Deficiency Syndrome (AIDS).
  11. Patients with increased risk for lactic acidosis:

    • severe congestive heart failure (NYHA: class III or IV),
    • history of metabolic acidosis,
    • alcoholic intake of > 3 drinks daily,
    • severe liver disease,
    • renal failure
  12. Known hypersensitivity or allergy to Metformin.
  13. Known pregnancy or lactating female patient.
  14. Geographic inaccessibility for follow-up.
  15. Inability to provide informed consent.

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): NCT02115464


Locations
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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
Walker Family Cancer Centre - Niagara Health System
St. Catharines, Ontario, Canada
Canada, Quebec
Montreal General Hospital - McGill
Montreal, Quebec, Canada
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Theodoros Tsakiridis, MD Juravinski Cancer Centre, Hamilton, Ontario, Canada

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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT02115464     History of Changes
Other Study ID Numbers: OCOG-2014-ALMERA
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Metformin
Non-small cell lung cancer
Locally advanced
Chemo-radiotherapy
Lung cancer treatment

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Metformin
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Antineoplastic Agents
Hypoglycemic Agents
Physiological Effects of Drugs