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Study on the Effects of Different Dosing Schedules of Irinotecan Hydrochloride, Calcium Folinate, and Fluorouracil in Patients with Metastatic Colorectal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on metastatic colorectal cancer, which is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. The study compares two different dosing schedules of FOLFIRI (a chemotherapy regimen that combines several medications) when used as first-line treatment for patients with this type of cancer. The purpose is to determine if giving this chemotherapy every three weeks is as effective as giving it every two weeks in terms of how long patients live without their cancer getting worse.

The treatment involves FOLFIRI chemotherapy, which is a standard treatment option for metastatic colorectal adenocarcinoma (a specific type of colorectal cancer). During the study, patients will receive this chemotherapy either every two weeks or every three weeks. The research team will monitor how the cancer responds to treatment using specialized imaging criteria called RECIST (Response Evaluation Criteria in Solid Tumors).

Patients in this study will have their cancer assessed regularly to determine how well the treatment is working. The researchers will track how long patients remain without their cancer progressing, overall survival time, duration of treatment, and any side effects that occur during the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the Study
After joining the study, you will be assigned to one of two treatment schedules for chemotherapy: either every 2 weeks (biweekly) or every 3 weeks (triweekly).
Before starting treatment, your tumor will be tested for molecular characteristics (RAS/RAF status and MSI status) to better understand your cancer type.
Step 2
FOLFIRI Chemotherapy Treatment
You will receive a combination chemotherapy regimen called FOLFIRI, which consists of three medications:
• Irinotecan hydrochloride: A medication that prevents cancer cells from dividing
• Calcium folinate (also known as leucovorin): A medication that enhances the effects of fluorouracil
• Fluorouracil: A medication that stops cancer cells from making DNA and RNA, preventing them from growing
The timing of your treatment will depend on which group you are assigned to: either every 2 weeks or every 3 weeks.
Step 3
Regular Tumor Assessments
Throughout the study, you will have regular CT scans (computed tomography) with contrast agents to measure your tumors.
These scans will determine if your cancer is responding to treatment, staying the same size, or growing.
The doctor will evaluate your response using standard criteria called RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).
Step 4
Monitoring Side Effects
During treatment, your doctor will monitor you for any side effects or complications.
Side effects will be categorized according to CTCAE v.5 (Common Terminology Criteria for Adverse Events), which is a standardized system for classifying the severity of side effects.
You will need to report any unusual symptoms or changes in your health to your healthcare team.
Step 5
Continuing Treatment
You will continue receiving the FOLFIRI treatment as long as:
• Your cancer is not growing (progressing)
• You do not experience severe side effects that require stopping treatment
• You do not choose to withdraw from the study
Step 6
End of Treatment
Treatment will end if your cancer starts growing (progression), if you experience severe side effects, or if you choose to withdraw from the study.
The study will track how long you were able to stay on treatment (Time on Treatment or ToT).
Step 7
Follow-up Period
After treatment ends, you will continue to be monitored to track your overall survival and any long-term effects.
The study is scheduled to run until July 2025, with final data collection until July 2031.

Who can join the trial?

14 criteria

Age 18 or older (no upper age limit)
Diagnosed with metastatic colorectal adenocarcinoma (a type of cancer that started in the colon or rectum and has spread to other parts of the body), confirmed by tissue examination
Not eligible for or refusing targeted biological therapy (specialized treatments that target specific features of cancer cells)
Willing to give consent to participate in the study
ECOG performance score between 0-2 (a scale measuring a patient's ability to perform daily activities, where 0 means fully active and 2 means able to perform self-care but unable to work)
Normal blood counts and organ functions:
- Liver tests (AST, GOT, GPT) and kidney function (creatinine) below three times the normal upper limit
- Bilirubin (a liver function test) below 5 times the normal upper limit
- Neutrophil count (a type of white blood cell) greater than 1.5 G/L
- Platelet count greater than 100 G/L
- Disease that can be measured according to RECIST 1.1 (standard criteria for measuring tumor response to treatment)
- Ability to undergo CT scans with contrast agents
- Using effective birth control methods
- Life expectancy of at least 3 months as determined by your doctor
- Must have tumor testing for RAS/RAF mutations and MSI status (tests that help determine cancer characteristics and potential treatment options)

Who cannot join the trial?

13 criteria

You cannot participate if you are under 18 years of age.
You cannot participate if you have had previous treatment for metastatic colorectal cancer (cancer that has spread from the colon or rectum to other parts of the body).
You cannot participate if you have had chemotherapy in the past 6 months.
You cannot participate if you have had radiation therapy to more than 30% of your bone marrow.
You cannot participate if you have other types of cancer that are active or were treated in the last 5 years (except for certain skin cancers or cervical cancer that have been adequately treated).
You cannot participate if you have serious heart conditions like heart failure, heart attack in the last 6 months, or uncontrolled angina (chest pain).
You cannot participate if you have uncontrolled high blood pressure.
You cannot participate if you have severe kidney or liver problems.
You cannot participate if you have active infections requiring treatment.
You cannot participate if you have peripheral neuropathy (nerve damage causing numbness or tingling in hands/feet) of grade 2 or higher.
You cannot participate if you are pregnant or breastfeeding.
You cannot participate if you are unwilling to use effective contraception during the study (if applicable).
You cannot participate if you have any condition that would make it unsafe for you to receive the study treatment or that might interfere with the study results.

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Verified sites

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University Of Pecs
Pecs, Hungary

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Investigated drugs

FOLFIRI Chemotherapy is a combination treatment used for metastatic colorectal cancer. This treatment includes three medications: fluorouracil (also called 5-FU), leucovorin (also called folinic acid), and irinotecan. These medications work together to stop cancer cells from growing and dividing.

What is already known about the treatment

FOLFIRI – A chemotherapy regimen used for treating metastatic colorectal cancer, administered intravenously in cycles typically every 2 or 3 weeks. FOLFIRI consists of a combination of three medications: folinic acid (leucovorin), fluorouracil (5-FU), and irinotecan. It works by interfering with DNA synthesis and cell division, preventing cancer cells from growing and multiplying. This regimen is classified as a cytotoxic combination chemotherapy and is primarily indicated for first-line palliative treatment of metastatic colorectal carcinoma, with effectiveness demonstrated in numerous clinical studies.

Investigated diseases

Metastatic colorectal cancer is an advanced form of colorectal cancer where the cancer has spread from the colon or rectum to other parts of the body. It begins as abnormal cell growth in the inner lining of the colon or rectum and progresses through the layers of the bowel wall. As the disease advances, cancer cells can break away from the primary tumor and travel through the bloodstream or lymphatic system to distant organs, most commonly the liver and lungs. The progression of metastatic colorectal cancer typically involves the growth of secondary tumors in these distant sites, which can affect the function of these organs. Symptoms may develop gradually and can include abdominal pain, changes in bowel habits, unexplained weight loss, and fatigue.