Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy (ALMERA)
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|ClinicalTrials.gov Identifier: NCT02115464|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2014
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Metformin plus Chemo-radiotherapy Radiation: Chemo-radiotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
- Progression free survival [ Time Frame: 12 months ]Progression free survival illustrates loco-regional disease control and freedom from distant metastasis
- 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.
- 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
- 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.
- 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.
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
|Cross Cancer Institute|
|Edmonton, Alberta, Canada|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|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|
|Montreal General Hospital - McGill|
|Montreal, Quebec, Canada|
|Principal Investigator:||Theodoros Tsakiridis, MD||Juravinski Cancer Centre, Hamilton, Ontario, Canada|