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Recruiting NCT06826092

Metformin for the Treatment of mCRC Patients Undergoing FOLFIRI Plus Target Therapy

Phase II Interventional Progression-Free Survival

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin Pill, FOLFIRI plus target therapy only.
Who it may be relevant to
Registry conditions: Progression-Free Survival. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Metformin as an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy

Overview

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

  • Drug Metformin Pill
    Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy
  • Drug FOLFIRI 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

Primary outcome measures

  • Disease progression-free survival (PFS) [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • Aged between 20 and 90 years old
  • Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy
  • 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)
  • 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)
  • Those who are not allergic to the relevant drugs required for the test
  • Those who can follow the doctor's order to take the medicine
  • Subjects must be willing to sign the consent form
  • 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

  • Patients other than the above-mentioned main inclusion criteria.
  • Non-native speakers
  • Known allergy to metformin or any of its components.
  • Severe instability in diabetes (ketoacidosis).
  • Blood sugar level lower than 80 mg/dL
  • Heart failure, respiratory insufficiency.
  • inadequate hematopoietic function defined as below:
  • hemoglobin < 9 g/dL;
  • absolute neutrophil count (ANC) < 1,500/mm3;
  • platelet count < 100,000/mm3;
  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Chung-Ho Memorial Hospital, Kaohsiung Medical University: — Kaohsiung City

Identifiers

NCT: NCT06826092 · KMUHIRB-F(I)-20220106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗