Randomised phase II trial of definitive radiotherapy with or without metformin in patients with inoperable stage III non-small cell lung cancer - RADFORMI

Antwerp University Hospital, Department Thoracic Oncology0 sites104 target enrollmentMarch 19, 2018

Overview

No summary available.

Registry

who.int

Start Date

March 19, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Antwerp University Hospital, Department Thoracic Oncology

•1\. Provision of signed and dated informed consent form.
•2\. Stated willingness to comply with all study procedures and availability for the duration of the study.
•3\. Ability to take oral medication and willing to adhere to the RADFORMIN\-regimen.
•4\. Male or female, \= 18 years of age.
•5\. Histological or cytological proven stage III NSCLC after adequate staging with at least FDG\-PET\-CT scan, contrast enhanced CT\-thorax and contrast\-enhanced CT/MRI brain.
•6\. Absence of diabetes, (diabetes is defined as fasting plasma glucose \>126 mg/dL or random plasma glucose \>200 mg/dL).
•7\. Eastern Cooperative Oncology Group (ECOG) performance score (\=WHO score) of 0\-1\.
•8\. Adequate hematologic, hepatic and renal function as follows:
•a. Bone Marrow: Absolute neutrophil count ANC \= 1,500/mm3 (1\.5 x 109/L); White blood cells \= 3,000/mm3 (3 x 109/L); Platelets \= 100,000/mm3 (100 x 109/L); Haemoglobin \= 9 g/dL (5\.58 mmol/L).
•b. Renal function: creatinine clearance of \=50 mL/min.

•1\. Current use of metformin, insulin or other oral antidiabetic drugs (thiazolidinediones, sulfonylureas, metiglinides, alpha\-glucosidase inhibitors, incretin mimitics, dipaptidyl peptidase\-4 inhibitors, amylin analogues, SGLT\-2\-inhibitors) for any reason.
•2\. Evidence for metastatic disease.
•3\. Conditions associated with increased risk of metformin\-associated lactic acidosis: New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, known kidney injury or disease, alcoholic liver disease or habitual intake of 3 or more alcoholic beverages per day.
•4\. Known pregnancy or lactating female patients.
•5\. Known allergic reactions to components of metformin.
•6\. Prior invasive malignancy within the past year (in remission, without evidence for current active disease and without maintenance therapy). Except non\-melanomatous skin cancer, non\-invasive carcinoma in\-situ of the breast, oral cavity or cervix.
•7\. Known acquired immune deficiency syndrome.