Recruiting

Study comparing oxaliplatin and irinotecan chemotherapy effectiveness using tumor testing in patients with metastatic colorectal cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on patients with metastatic colorectal cancer, specifically the MSS/pMMR subtype. The research aims to test a new approach using patient-derived tumouroids (laboratory-grown tumor cells) to help doctors choose between two different chemotherapy combinations for treatment. The study compares two treatment options: an oxaliplatin-based therapy and an irinotecan-based therapy, both given through intravenous infusion.

The treatments being studied include two different combinations of chemotherapy drugs. The first combination contains Oxaliplatin Fresenius Kabi as a solution for infusion, which can be given up to 200 mg per square meter of body surface area per day. The second combination contains Irinotecan Fresenius Kabi as a solution for infusion, which can be given up to 400 mg per square meter of body surface area per day. Both treatments may be given for up to 12 months.

During the study, small samples of tumor tissue will be collected and grown in a laboratory to create tumouroids. These laboratory-grown samples will be tested to see how they respond to different chemotherapy combinations. This information will help determine which treatment might work better for each patient. The study will track how well patients respond to treatment, how long the treatment keeps the cancer under control, and any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment evaluation
Your doctor will evaluate if you are eligible for two types of chemotherapy: FOLFOX (oxaliplatin-based) or FOLFIRI (irinotecan-based)
Both treatments must be equally suitable for your specific case of metastatic colorectal cancer
Step 2
Treatment assignment
Based on laboratory analysis of your tumor tissue, you will be assigned to receive either:
Oxaliplatin (Oxaliplatin Fresenius Kabi) through intravenous infusion
Or
Irinotecan (Irinotecan Fresenius Kabi) through intravenous infusion
Step 3
Treatment monitoring
Your response to treatment will be regularly monitored using imaging scans
Side effects will be tracked and recorded using standard medical criteria
Your overall health status will be regularly assessed
Step 4
Ongoing evaluation
Your doctor will monitor how well the cancer responds to treatment
Regular checks will be performed to measure if the cancer is stable, shrinking, or growing
Treatment will continue as long as it is providing benefit and side effects are manageable
Step 5
Follow-up period
After treatment completion, regular follow-up visits will be scheduled to monitor your health
The study will track your progress for an extended period to evaluate long-term outcomes

Who can join the trial?

8 criteria

You must be 18 years of age or older
You must be willing and able to provide written informed consent to participate in the study
You must have a good level of physical function (ECOG performance status of 0 or 1, meaning you are either fully active or restricted only in strenuous physical activity)
You must have confirmed colon or rectal cancer with specific characteristics (pMMR/MSS type) proven by tissue examination
Your doctor must determine that two specific chemotherapy treatments (FOLFOX or FOLFIRI, with or without additional antibody therapy) are equally suitable as your first treatment option
Your cancer must be metastatic (spread to other parts of the body) and not suitable for complete surgical removal
You must have cancer that can be measured or evaluated using standard imaging criteria (RECIST 1.1)
You must be able to receive full-strength chemotherapy doses when starting treatment

Who cannot join the trial?

12 criteria

Previous participation in another clinical trial within the last 30 days
Known hypersensitivity (severe allergic reaction) to any of the study medications or their ingredients
Presence of any other type of cancer besides metastatic colorectal cancer (cancer that has spread from the colon/rectum to other parts of the body)
Severe heart, liver, or kidney disease that is not well controlled
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Pregnancy or breastfeeding
Mental conditions that could interfere with following study procedures
Unable to provide informed consent
History of organ transplantation
Any serious medical condition that the study doctor believes could make it unsafe to participate
Current substance abuse or alcohol dependency
Unable to swallow oral medications

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Verified sites

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Verified
St. Olavs Hospital HF
Trondheim, Norway

Trial locations

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Investigated drugs

Oxaliplatin is a chemotherapy medication used to treat colorectal cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. This medication is often combined with other drugs to create a more effective treatment for metastatic colorectal cancer. Irinotecan is another chemotherapy medication used in the treatment of colorectal cancer. It works by blocking an enzyme that cancer cells need to divide and grow. This medication is commonly used when cancer has spread to other parts of the body (metastatic cancer). Both medications are being compared in this study using patient-derived tumouroids (laboratory-grown mini versions of patient tumors) to help determine which treatment might work better for individual patients with metastatic colorectal cancer.

What is already known about the treatment

Oxaliplatin
A platinum-based chemotherapy drug administered intravenously for treating colorectal cancer, particularly in its metastatic form. It works by forming cross-links in DNA, which prevents cancer cells from dividing and leads to their death. This medication belongs to the platinum-containing antineoplastic agents class and is typically used in combination with other chemotherapy drugs as part of standard treatment protocols for colorectal cancer.
Irinotecan
An antineoplastic agent given through intravenous infusion that is commonly used to treat metastatic colorectal cancer. It functions by inhibiting topoisomerase I, an enzyme essential for DNA replication, thereby preventing cancer cells from multiplying. This medication belongs to the topoisomerase inhibitors class and is often used either alone or in combination with other chemotherapy drugs, particularly when treating advanced stages of colorectal cancer.

Investigated diseases

Metastatic Colorectal Cancer (MSS/pMMR) - A form of colorectal cancer that has spread beyond the original site to other parts of the body, specifically characterized by microsatellite stable (MSS) and proficient mismatch repair (pMMR) status. This type of cancer begins in the colon or rectum and develops when healthy cells in these areas change and grow out of control, forming a mass called a tumor. The MSS/pMMR subtype represents the most common form of colorectal cancer, characterized by stable DNA repair mechanisms. As the disease progresses, cancer cells can break away from the primary tumor and travel through the blood or lymphatic system to form new tumors in other organs, most commonly the liver and lungs.