Recruiting

Study on Using ctDNA to Guide Treatment in Patients with Metastatic Colorectal Cancer Using Oxaliplatin, Capecitabine, Calcium Folinate, Irinotecan, and Fluorouracil

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 clinical trial is focused on studying colorectal cancer with metastasis, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The study aims to explore the use of circulating tumor DNA analysis, a method that examines small pieces of DNA from cancer cells found in the blood, to guide treatment decisions for patients with this condition. The trial will involve several medications, including oxaliplatin, capecitabine, calcium folinate (also known as leucovorin calcium), irinotecan hydrochloride, and fluorouracil (also known as 5-FU). These medications are commonly used in chemotherapy, which is a treatment that uses drugs to kill cancer cells.

Participants in the study will receive treatment over a period of time, with some medications given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein, and others taken orally, which means they are swallowed in pill form. The study will compare the effectiveness of these treatments in preventing the return of cancer and improving overall survival rates. The goal is to determine if using circulating tumor DNA analysis can help doctors make better treatment choices for patients with oligometastatic colorectal cancer, which is a stage where the cancer has spread but is still limited to a few areas.

The trial will monitor various outcomes, such as the rate of patients who remain free from cancer recurrence two years after starting the study, the side effects experienced by participants, and the overall quality of life. By understanding these factors, the study hopes to improve the way treatments are selected and followed up for patients with metastatic colorectal cancer, ultimately aiming to enhance patient care and outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.
Informed consent is obtained, ensuring understanding of the study's purpose and procedures.
Step 2
Treatment initiation
The treatment involves a combination of medications administered in different forms.
The medications include oxaliplatin, capecitabine, calcium folinate, irinotecan hydrochloride, and fluorouracil.
Step 3
Medication administration
Oxaliplatin is given through an intravenous infusion.
Capecitabine is taken orally.
Calcium folinate is administered via intravenous infusion.
Irinotecan hydrochloride is given through an intravenous infusion.
Fluorouracil is administered via intravenous infusion.
Step 4
Treatment monitoring
Regular monitoring is conducted to assess the response to treatment and manage any side effects.
The primary goal is to remain free from recurrent colorectal cancer for two years after inclusion.
Step 5
Follow-up assessments
Follow-up assessments occur to evaluate the rate of toxicity, response to therapy, and overall survival.
Quality of life is also assessed using specific questionnaires.
Step 6
Study completion
The study is estimated to conclude by March 31, 2031.
Final evaluations are conducted to determine the long-term outcomes and effectiveness of the treatment.

Who can join the trial?

9 criteria

The patient must have **colorectal cancer** that has spread to other parts of the body.
The patient should be planned for a treatment that aims to remove or destroy the cancer spread, using methods like surgery, radiofrequency ablation (RFA), or stereotactic body radiation therapy (SBRT). Other experimental local treatments are also considered, but not cytoreductive surgery (CRS) or hyperthermic intraperitoneal chemotherapy (HIPEC).
There should be no signs of additional disease based on standard medical checks before treatment.
The patient must be at least 18 years old.
The patient should have an **ECOG performance status** of 0 to 2, which means they are fully active or have some limitations but can still take care of themselves.
The patient should be considered suitable for additional chemotherapy treatment by the doctor.
The patient must have good enough **bone marrow, liver, and kidney function** to handle chemotherapy. This includes having enough white blood cells and platelets, normal bilirubin levels, and a good kidney filtration rate.
If the patient is a woman who can have children, or a man with a partner who can have children, they must use birth control. Acceptable methods include an intrauterine device, vasectomy of the male partner, or hormonal contraceptives.
The patient must provide written and verbal consent to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have colorectal cancer with metastasis cannot participate. This means the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both men and women can participate, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population are not excluded. This means people who might need extra protection are not automatically left out.

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Verified sites

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

Asklepios Kliniken Hamburg GmbH
Verified
Hamburg, Germany
Oslo Universitetssykehus HF
Verified
Oslo, Norway
Region Midtjylland
Responsive
Aarhus, Denmark

Trial locations

Where you can join this trial

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Investigated drugs

Circulating Tumor DNA Analysis is a method used in this trial to help guide treatment decisions for patients with oligometastatic colorectal cancer. This analysis involves examining small fragments of DNA that are released from cancer cells into the bloodstream. By analyzing these fragments, doctors can gain insights into the genetic makeup of the cancer, which can help in selecting the most effective treatment options for each patient.

What is already known about the treatment

Bevacizumab – Bevacizumab is administered intravenously and is used in the treatment of metastatic colorectal cancer. It is currently well-established in medical practice and literature as a treatment option for various cancers, particularly those with metastasis. The main therapeutic indication for Bevacizumab is to inhibit the growth of blood vessels that supply tumors, thereby slowing or stopping tumor growth. At the molecular level, it works by blocking a protein called vascular endothelial growth factor (VEGF), which is responsible for the formation of new blood vessels. Bevacizumab is classified as an angiogenesis inhibitor in pharmacology.

Investigated diseases

Colorectal Cancer with Metastasis – This disease begins in the colon or rectum and can spread to other parts of the body, such as the liver or lungs. Initially, it may develop from benign growths called polyps, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and organs, leading to metastasis. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower course. Metastatic colorectal cancer often requires complex management due to its ability to affect multiple body systems.