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Study on Oxaliplatin and Irinotecan for Patients with Metastatic Colorectal Cancer in the Liver

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 metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to the liver. The study is exploring the use of a treatment called oxaliplatin, which is a medication given as a solution for infusion, meaning it is administered directly into the bloodstream. The trial is comparing two methods of delivering oxaliplatin: one is through the veins, known as intravenous administration, and the other is directly into the arteries, known as intra-arterial administration. The study also involves additional treatments, including a combination of chemotherapy drugs called LV5FU2 and sometimes irinotecan, along with targeted therapy, which is a type of treatment that targets specific cancer cells.

The purpose of the study is to compare how well the cancer responds to these different methods of treatment. Participants will receive either the intravenous or intra-arterial administration of oxaliplatin, along with the other treatments, to see which method is more effective in controlling the cancer. The study will monitor the progression of the disease using imaging techniques and clinical evaluations to determine how long the cancer can be kept from worsening. The trial will also assess the side effects of the treatments and their impact on the participants' quality of life.

Throughout the study, participants will undergo regular check-ups and imaging tests to track the cancer's response to the treatment. The trial aims to provide valuable information on the best approach to treating metastatic colorectal cancer that has spread to the liver, potentially improving outcomes for patients with this condition. The study is expected to continue until 2026, allowing researchers to gather comprehensive data on the effectiveness and safety of the treatments being tested.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial and will sign a consent form. This step ensures that the patient understands the trial's purpose and procedures.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of colorectal cancer with liver metastasis and other health criteria.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of the treatment groups. This process determines whether the patient will receive oxaliplatin through intra-arterial or intravenous administration.

  4. Step 4

    Treatment administration

    The patient will receive oxaliplatin as part of a chemotherapy regimen. The administration can be either intra-arterial or intravenous, depending on the assigned group.

    The treatment may also include LV5FU2 and possibly irinotecan, along with targeted therapy. The specific combination and dosage will be determined by the treatment plan.

  5. Step 5

    Monitoring and evaluation

    The patient's response to treatment will be monitored regularly. This includes assessing tumor size and progression using imaging techniques.

    Adverse events will be recorded and graded according to established criteria. The patient's overall health and quality of life will also be evaluated.

  6. Step 6

    Follow-up

    After completing the treatment cycles, the patient will continue to be monitored for any changes in health status. This includes checking for tumor progression or recurrence.

    The follow-up period aims to gather data on long-term outcomes and overall survival.

Who can join the trial?

13 criteria

  • The patient must have a type of cancer called **colorectal adenocarcinoma** that has spread to the liver.
  • The patient must have certain blood test results: **total bilirubin** less than 25 micromoles per liter, **AST** and **ALT** less than 5 times the upper normal limit, **ALP** less than 5 times the upper normal limit, **PT** greater than 60%, and **proteinuria** less than 1 gram in 24 hours.
  • The patient must have a **creatinine clearance** greater than 50 milliliters per minute, which is a measure of kidney function.
  • The patient must be part of a social security scheme.
  • The patient must have received information about the study and signed a consent form agreeing to participate.
  • The patient must have at least one liver tumor that can be measured according to specific criteria called **RECIST v1.1**.
  • The patient should not have cancer spread to other parts of the body, except for up to 3 small lung nodules that are less than 10 millimeters.
  • The patient's **RAS mutation status** must be known, which involves checking for specific changes in genes called **KRAS** and **NRAS**.
  • The patient must be 18 years old or older.
  • The patient must have a **performance status** of 2 or less, which is a measure of their ability to perform daily activities.
  • The patient should not have had previous chemotherapy, except for certain types that were stopped more than 12 months ago, and the first course of specific treatments called **FOLFOX** or **mFOLFIRINOX** without targeted therapy before being assigned to a treatment group.
  • The patient must have a life expectancy of more than 3 months.
  • The patient must have certain blood cell counts: **PNN** greater than 1500 per cubic millimeter, **platelets** greater than 100,000 per cubic millimeter, and **hemoglobin** greater than 9 grams per deciliter.

Who cannot join the trial?

5 criteria

  • Patients who do not have colon cancer or rectal cancer with liver metastasis cannot participate. Metastasis means that the cancer has spread to the liver.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means that only certain groups of patients are eligible.
  • Both female and male patients are eligible, so exclusion is not based on gender.
  • Patients who are considered part of a vulnerable population may not be eligible. This term refers to groups who might need special protection or care.
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Investigated drugs

  • Oxaliplatin

    This medication is used in the treatment of metastatic colorectal cancer. It is a type of chemotherapy that works by interfering with the growth of cancer cells. In this trial, oxaliplatin is administered either directly into the liver's blood supply (intra-arterial) or through a vein (intravenous).

  • LV5FU2

    This is a chemotherapy regimen that includes a combination of two drugs, leucovorin and fluorouracil. It is used to enhance the effectiveness of chemotherapy by helping to stop the growth of cancer cells.

  • Irinotecan

    This is another chemotherapy drug that is sometimes added to the treatment regimen. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

  • Targeted Therapy

    This type of treatment uses drugs or other substances to precisely identify and attack cancer cells, usually while doing little damage to normal cells. The specific targeted therapy used in this trial is not named, but it is used in combination with chemotherapy to improve treatment outcomes.

What is already known about the treatment

Oxaliplatin – This medication is administered either intravenously or intra-arterially, depending on the treatment plan. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer that has spread to the liver. Oxaliplatin is primarily used in combination with other chemotherapy drugs to treat advanced colon and rectal cancer. It works by interfering with the DNA in cancer cells, preventing them from growing and dividing. Oxaliplatin is classified as a platinum-based chemotherapy drug.

Investigated diseases

  • Colon Cancer with Liver Metastasis

    This is a type of cancer that begins in the colon and spreads to the liver. It typically starts as a growth on the inner lining of the colon, which can become cancerous over time. As the disease progresses, cancer cells can travel through the bloodstream or lymphatic system to the liver, forming secondary tumors. Symptoms may include changes in bowel habits, abdominal pain, and weight loss. The progression of the disease can vary, with some tumors growing slowly while others may spread more rapidly. The presence of liver metastasis often indicates an advanced stage of the disease.

  • Rectal Cancer with Liver Metastasis

    This cancer originates in the rectum and can spread to the liver. It usually begins as a polyp in the rectum, which can develop into cancer over time. As the disease advances, cancer cells may migrate to the liver, leading to the formation of metastatic tumors. Symptoms can include rectal bleeding, changes in bowel habits, and abdominal discomfort. The progression of rectal cancer with liver metastasis can differ among individuals, with some experiencing slow growth and others facing more aggressive spread. Liver metastasis typically signifies a more advanced stage of rectal cancer.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518553-41-00Protocol codePRODIGE 49 -OSCAREstimated enrolment348 patientsSponsorFondation Franc.Cancerologie Digestive

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