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Study on the Effects of Fluorouracil and Capecitabine 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

The study focuses on understanding the behavior and treatment outcomes of metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study aims to evaluate how this cancer behaves, its potential for surgical removal, and the recovery and survival of patients after surgery. Two medications are being used in this study: Fluorouracil, which is given as an injection or infusion, and Capecitabine, which is taken as a tablet. Both medications are types of antineoplastic agents, which are drugs used to treat cancer by stopping the growth of cancer cells.

The purpose of the study is to assess the clinical behavior of metastatic colorectal cancer and determine the overall possibility of surgically removing the cancer, as well as to observe any complications after surgery and the outcomes for patients. Participants in the study will receive either Fluorouracil or Capecitabine as part of their treatment plan. The study will monitor the patients over a period to gather information on how well the treatments work and the overall health and recovery of the patients.

This research is important for improving the understanding of metastatic colorectal cancer and finding better ways to treat it. By studying the effects of these medications and the potential for surgery, the study aims to provide valuable insights that could lead to improved treatment strategies and outcomes for patients with this type of cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of metastatic or locally advanced inoperable colorectal cancer.
Eligibility is confirmed through a review of medical history and current health status. A signed informed consent is required before participation.
Step 2
Treatment initiation
The treatment phase begins with the administration of chemotherapy. Two medications are used: fluorouracil and capecitabine.
Fluorouracil is administered as an infusion. The specific dosage and frequency are determined by the healthcare provider based on individual patient needs.
Capecitabine is taken orally in the form of film-coated tablets. The dosage and frequency are also tailored to the patient's condition.
Step 3
Monitoring and evaluation
Throughout the trial, regular monitoring is conducted to assess the clinical behavior of the cancer and the patient's response to treatment.
Evaluations include checking the resectability of the cancer, which refers to the possibility of surgically removing the tumor, and monitoring for any postoperative complications if surgery is performed.
Step 4
Follow-up
The trial includes a follow-up phase to evaluate long-term outcomes and survival rates.
This phase continues until the estimated end date of the trial, which is December 31, 2025.

Who can join the trial?

5 criteria

Patients must have **colorectal cancer** that has been confirmed by a test called a **histological test**. This means a sample of the cancer was looked at under a microscope to confirm the diagnosis.
Patients should be starting or already receiving their first treatment with **chemotherapy** for cancer that has spread to other parts of the body, known as **metastatic disease**.
Patients must be at least 18 years old.
The cancer must be **metastatic**, which means it has spread beyond the original site, or it must be **locally advanced**, meaning it has grown too much to be removed by surgery or treated with radiation or chemotherapy.
Patients need to sign a document called **informed consent**. This document explains the study and confirms that the patient agrees to participate. It follows specific guidelines and has been approved by an ethics committee.

Who cannot join the trial?

4 criteria

Patients with **metastatic** or **locally advanced inoperable colorectal cancer** cannot participate. This means the cancer has spread to other parts of the body or is in a location that cannot be surgically removed.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who do not fit into the specific clinical trial groups outlined by the study cannot participate.
Patients who are part of a **vulnerable population** are not eligible. This refers to groups who may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Helsinki University Central Hospital
Helsinki, Finland
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Kuopio University Hospital
Kuopio, Finland
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Oulu University Hospital
Oulu, Finland

Trial locations

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Investigated drugs

RAXO: This is a study focused on understanding how metastatic colorectal cancer behaves in patients. The goal is to see how often the cancer can be surgically removed, what complications might occur after surgery, and how these factors affect patient survival. The study is conducted in Finland and aims to gather information that could help improve treatment strategies for this type of cancer.

What is already known about the treatment

RAXO trial medication – This medication is administered orally or intravenously, depending on the specific drug formulation used in the trial. It is currently under investigation in clinical trials, specifically the RAXO trial, which focuses on metastatic or locally advanced inoperable colorectal cancer. The main therapeutic indication is to evaluate the clinical behavior, resectability, and survival outcomes in patients with this type of cancer. The medication works by targeting specific molecular pathways involved in cancer cell growth and proliferation, aiming to inhibit tumor progression. It is classified pharmacologically as an antineoplastic agent, which is a type of drug used to treat cancer.

Investigated diseases

Metastatic Colorectal Cancer
This is a type of cancer that begins in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It often starts as a growth, called a polyp, on the inner lining of the colon or rectum. Over time, some polyps can turn into cancer. Once the cancer cells spread beyond the original site, it is considered metastatic. The progression can vary, with some cases spreading quickly while others may grow more slowly. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.
Locally Advanced Inoperable Colorectal Cancer
This form of colorectal cancer has spread to nearby tissues or lymph nodes but cannot be removed completely through surgery. It typically involves a large tumor that has invaded surrounding structures, making surgical removal challenging. The disease may cause symptoms such as bowel obstruction, pain, and bleeding. As the cancer grows, it can affect the function of nearby organs. The progression of the disease can lead to increased symptoms and complications. Management often focuses on controlling the growth and alleviating symptoms.