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Study on Treatment for Colorectal Liver Metastases Using Heparin, Dexamethasone, and Floxuridine for Patients with Heavy Tumor Burden

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What is this study about?

This clinical trial is focused on studying treatments for Colorectal Liver Metastases, which are cancerous growths that have spread to the liver from the colon or rectum. The study will use several medications, including Heparin, a blood thinner, Dexamethasone Acetate, a type of steroid, Dexamethasone Sodium Phosphate, another form of steroid, and Floxuridine, a chemotherapy drug. The purpose of the study is to evaluate the effectiveness of these treatments in improving overall survival over a period of two years.

Participants in the study will receive one or more of these medications through an intravenous infusion, which means the medicine is delivered directly into the bloodstream. The study will compare the effects of these medications on the participants’ health, including their ability to control the cancer and improve quality of life. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatments being tested.

The study will last for several years, with regular check-ups and assessments to monitor the participants’ health and response to the treatment. The goal is to determine if these medications can help patients live longer and manage their cancer more effectively. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of colorectal liver metastases. The patient should have previously received at least one line of systemic chemotherapy.

The patient must meet specific health criteria, including satisfactory blood tests and a good performance status. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.

2 treatment initiation

The treatment involves the administration of medications in the form of a concentrate for solution for infusion. The medications include heparin, dexamethasone acetate, dexamethasone sodium phosphate, and floxuridine.

The specific dosage, frequency, and duration of administration will be determined by the healthcare provider based on the patient’s condition and response to treatment.

3 monitoring and evaluation

Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular blood tests and imaging studies to assess the status of liver metastases.

The primary goal is to evaluate overall survival at two years, with secondary goals including progression-free survival, overall survival at five years, resection or transplantation rate, and quality of life.

4 completion of the trial

The trial is expected to continue until October 31, 2033. The patient’s participation will be concluded based on the trial’s timeline or if specific health criteria are met.

Upon completion, the patient’s overall health and treatment outcomes will be assessed to determine the effectiveness of the treatment regimen.

Who Can Join the Study?

  • The patient must have a type of cancer called adenocarcinoma in the colon or rectum, which has been confirmed by a test called histology.
  • The patient must have cancer that has spread to the liver, known as liver metastases, and meet one of the following conditions:
    • The liver tumors cannot be removed by surgery at the time of joining the study.
    • Surgery would require the tumors to shrink by 10% or more.
    • The patient needs a new type of chemotherapy because the current one is not working well, or it was stopped due to side effects.
    • The patient has a stable or partially reduced tumor size after the first round of chemotherapy but is unlikely to have surgery due to having many tumors in both sides of the liver or very large tumors.
  • The patient must have received at least one type of chemotherapy before joining the study and be planned for another type of chemotherapy.
  • If the patient has started a new chemotherapy, they must join the study before the first evaluation of this new treatment.
  • The patient must be in good health overall, with a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have satisfactory blood test results, including:
    • Hemoglobin (Hb) level above 9 g/dl.
    • Neutrophils (a type of white blood cell) above 1.0 after any treatment to boost them.
    • Platelets (TRC) above 75.
    • Bilirubin (a liver function test) less than 1.5 times the normal level.
    • Liver enzymes (ASAT, ALAT) less than 5 times the normal level.
    • Creatinine (a kidney function test) less than 1.25 times the normal level.
    • Albumin (a protein in the blood) above the lower normal level.
  • Women who can have children must have a confirmed menstrual cycle and a negative pregnancy test before joining the study, and agree to use a highly effective birth control method during the study and for 30 days after.
  • Men who may have sexual relations with women who can have children must agree to use a condom during the study and for 90 days after.
  • The patient must sign a document called informed consent, agreeing to participate in the study and follow the treatment and check-up schedule.

Who Cannot Join the Study?

  • Patients with medical conditions other than Colorectal Liver Metastases cannot participate.
  • Individuals who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Participants must not belong to a vulnerable population. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
01.02.2021

Trial locations

Investigated drugs:

Extended Criteria Treatment is a therapy being studied for its effectiveness in treating liver metastases with a heavy tumor burden. This treatment aims to improve the overall survival of patients over a period of two years. The specific details of the treatment are not provided, but it is part of a clinical trial focused on patients with significant liver metastases.

Investigated diseases:

Colorectal Liver Metastases – This condition occurs when cancer cells from the colon or rectum spread to the liver. It is a common progression for colorectal cancer, as the liver is a frequent site for metastasis due to its blood supply. The disease often develops without symptoms initially, but as it progresses, it may cause abdominal pain, weight loss, and jaundice. The growth of metastatic tumors in the liver can affect liver function and overall health. Over time, the liver’s ability to process nutrients and filter toxins may be compromised. The progression of the disease can vary, with some cases remaining stable for a period while others may advance more rapidly.

Trial ID:
2024-512397-95-00
NCT ID:
NCT04898504
Trial Phase:
Therapeutic exploratory (Phase II)

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