Actively Recruiting
Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy
Led by Kaohsiung Medical University Chung-Ho Memorial Hospital · Updated on 2025-02-13
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study progression-free survival (PFS) in patients with metastatic colorectal cancer who are treated with chemotherapy. It compares patients receiving FOLFIRI chemotherapy alone to those receiving FOLFIRI combined with Metformin, assessing whether adding Metformin affects how long patients live without disease progression. The study is a Phase 2 trial sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Participants are randomly assigned to one of two groups. The experimental group receives Metformin 500 mg three times daily along with FOLFIRI chemotherapy and a targeted therapy. The control group receives FOLFIRI chemotherapy plus targeted therapy without Metformin. FOLFIRI includes Leucovorin, 5-FU, and Irinotecan delivered through infusions over several hours. Treatment continues as per protocol with ongoing assessments. Throughout the study, patients will be monitored approximately every four weeks to track disease progression and survival status, up to 52 months or until death, loss to follow-up, or trial end. Researchers will collect data on progression-free survival as the main outcome. Patients must agree to follow treatment instructions and attend regular visits where blood sugar and organ functions are checked to ensure safety during the trial period.
CONDITIONS
Brief Title
Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 20 and 90 years old
- Diagnosed with metastatic colorectal cancer and scheduled to receive FOLFIRI chemotherapy
- Women must not be pregnant or breastfeeding and must use contraception during treatment
- No major cardiovascular, cerebrovascular, kidney, or liver diseases
- No allergies to study drugs
- Able to follow doctor's instructions to take medication
- Willing to sign informed consent
- Blood sugar level above 80 mg/dL
You will not qualify if you...
- Does not meet the main inclusion criteria
- Non-native speakers
- Known allergy to Metformin or any components
- Severe unstable diabetes such as ketoacidosis
- Blood sugar level below 80 mg/dL
- Heart failure or respiratory insufficiency
- Inadequate blood cell counts (hemoglobin < 9 g/dL, ANC < 1500/mm3, platelet count < 100,000/mm3)
- Inadequate liver or kidney function (bilirubin > 2x upper limit, ALT or AST > 2.5x upper limit, creatinine > 1.5x upper limit)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 months
Participants receive chemotherapy FOLFIRI plus target therapy with or without Metformin as part of the trial treatment.
Approximately monthly visits for treatment and assessment
Duration - Up to 52 months
Participants are followed to monitor progression-free survival and overall survival until death, loss of follow-up, or trial end.
Approximately monthly visits for survival status assessment
Trial Site Locations
Total: 1 location
1
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, Taiwan, 807
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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