Progression-Free Survival
Conditions
Brief summary
To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin
Detailed description
Objectives: 1. Main purpose • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin 2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin
Interventions
DRUGMetformin Pill
Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy
DRUGFOLFIRI plus target therapy only
FOLFIRI (Leucovorin (LV), 200 mg/m2, 2-hour infusion, 5-FU, 2,800 mg/m2, 46-hour infusion, Irinotecan (IRI), 180 mg/m2, 2-hour infusion) plus target therapy
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 20 and 90 years old 2. Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy 3. Female must not be planning to become pregnant or breastfeeding, and not pregnant at any point during treatment. (Contraception is required to participate in this trial) 4. Those without major physiological diseases (example of major cardiovascular disease is acute myocardial infarction; example of major cerebrovascular disease is acute stroke, malignant hypertension, acute kidney failure, acute liver failure) 5. Those who are not allergic to the relevant drugs required for the test 6. Those who can follow the doctor's order to take the medicine 7. Subjects must be willing to sign the consent form 8. Blood sugar level above 80 mg/dL
Exclusion criteria
Subjects who meet any of the following exclusion conditions are not allowed to join the trial 1. Patients other than the above-mentioned main inclusion criteria. 2. Non-native speakers 3. Known allergy to metformin or any of its components. 4. Severe instability in diabetes (ketoacidosis). 5. Blood sugar level lower than 80 mg/dL 6. Heart failure, respiratory insufficiency. 7. inadequate hematopoietic function defined as below: * hemoglobin \< 9 g/dL; * absolute neutrophil count (ANC) \< 1,500/mm3; * platelet count \< 100,000/mm3; 8. inadequate organ functions defined as below: * total bilirubin \> 2 times upper limit of normal (ULN); * hepatic transaminases (ALT and AST) \> 2.5 x ULN; * creatinine \> 1.5 x ULN;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression-free survival (PFS) | The trial will continue to follow (approximately every 4 weeks) the subject's survival status until death, loss of follow-up, end of trial, or termination of the trial, assessed up to 52 months | Disease progression-free survival (PFS) was defined as the date from the initiation of trial treatment until the date of the first imaging-confirmed progression or death (whichever occurred first) |
Countries
Taiwan
Outcome results
None listed