Study on the Effectiveness of Floxuridine and Drug Combination for Patients with Unresectable Colorectal Liver Metastases

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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 in the liver that originate from colorectal cancer. The study will compare two treatment approaches: one group will receive a combination of hepatic arterial infusion pump (HAIP) chemotherapy and systemic therapy, while the other group will receive systemic therapy alone. The systemic therapy includes medications such as irinotecan hydrochloride, oxaliplatin, capecitabine, fluorouracil, calcium folinate, bevacizumab, and dexamethasone acetate. Additionally, floxuridine will be used in the HAIP chemotherapy group. The purpose of the study is to determine if the combination of HAIP chemotherapy and systemic therapy can improve survival in patients with initially unresectable colorectal liver metastases compared to systemic therapy alone.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for up to 52 weeks, during which participants will receive their assigned treatments. The treatments will be administered through different methods, including intravenous (directly into a vein) and intra-arterial (directly into an artery) routes, depending on the specific medication. Some medications, like capecitabine, will be taken orally. The study will monitor the participants’ health and response to the treatments throughout the trial period.

The trial aims to assess various outcomes, including overall survival, progression-free survival, and the rate at which the cancer can be surgically removed after treatment. It will also evaluate the quality of life of participants and any side effects or complications that may arise from the treatments. The study will help determine the effectiveness of combining HAIP chemotherapy with systemic therapy in treating colorectal liver metastases.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments. Written informed consent is required.

2 initial assessment

An initial assessment is conducted to evaluate the current health status. This includes blood tests and imaging to confirm the presence of colorectal liver metastases.

3 treatment allocation

Participants are randomly assigned to receive either hepatic arterial infusion pump chemotherapy combined with systemic therapy or systemic therapy alone.

4 treatment phase

For those receiving the combination therapy, a catheter is placed for hepatic arterial infusion. The default site for catheter insertion is the gastroduodenal artery.

Medications administered include irinotecan hydrochloride, heparin, oxaliplatin, capecitabine, floxuridine, bevacizumab, fluorouracil, calcium folinate, and dexamethasone acetate. These are given through various routes such as intravenous, intraarterial, and oral, depending on the specific drug.

5 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment. This includes imaging and blood tests to evaluate tumor response and detect any side effects.

Participants are monitored for overall survival, progression-free survival, and other health outcomes.

6 end of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response and any potential for surgical resection of the liver metastases.

7 long-term follow-up

Participants enter a long-term follow-up phase to monitor for any recurrence of cancer and to assess long-term health outcomes and quality of life.

Who Can Join the Study?

Must be at least 18 years old.
The main tumor must be in place and can be removed with surgery without needing treatment before surgery.
Eligible for surgery.
Eligible for a type of chemotherapy that uses two drugs.
Must meet certain lab test results, which include:

Enough healthy blood cells and proper liver and kidney function.
Hemoglobin (Hb) level of at least 5.5 mmol/L.
Enough white blood cells, specifically neutrophils, with a count of at least 1.5 x 10⁹/L.
Platelet count of at least 100 x 10⁹/L.
Total bilirubin level no more than 1.5 times the normal upper limit.
ASAT/AST and ALAT/ALT levels no more than 5 times the normal upper limit.
Alkaline phosphatase level no more than 5 times the normal upper limit.
Serum creatinine level no more than 1.5 times the normal upper limit or a kidney function test (eGFR) of at least 45 ml/min.
Blood clotting time (prothrombin time or INR) less than 1.5 times the normal upper limit, unless taking certain blood thinners. If taking these, they will be switched to other types of blood thinners.

Must provide written consent to participate, following specific guidelines and regulations.
Must have a confirmed diagnosis of colorectal adenocarcinoma, a type of cancer.
Must have liver metastases from colorectal cancer that cannot be removed by surgery, as confirmed by a specific medical panel using a CT scan done within 4 weeks before joining the study.
No cancer spread outside the liver. Small spots outside the liver that are not clearly cancerous are allowed.
No previous treatment with drugs that affect the whole body for colorectal cancer.
It must be possible to place a special tube (catheter) for a specific type of chemotherapy in the liver, based on imaging tests. Certain conditions about liver arteries must be met.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but being able to do light work.
Must have a life expectancy of at least 12 weeks.
Must know the mutation status of specific genes called RAS and BRAFV600E.

Who Cannot Join the Study?

Patients who have had previous chemotherapy for their liver metastases cannot participate. This means if you have already received drug treatment for cancer that has spread to the liver, you are not eligible.
Patients with other serious health conditions that could interfere with the study. This means if you have other major health problems, you might not be able to join.
Patients who are pregnant or breastfeeding. This means if you are expecting a baby or nursing, you cannot take part in the study.
Patients who are unable to follow the study procedures. This means if you cannot comply with the study requirements, you are not eligible.
Patients with allergies to the study drugs. This means if you have a known allergy to the medications used in the study, you cannot participate.
Patients with certain infections that could affect the study. This means if you have specific infections, you might not be able to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Stichting OLVG	Amsterdam	The Netherlands
Frisius	Heerenveen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Isala Klinieken Stichting	Zwolle	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Amphia Hospital	Breda	The Netherlands
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Deventer Ziekenhuis	Deventer	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Lkbrc Uahyqydolguv Mduxtft Chnnoni (hgzwm	Leiden	The Netherlands
Ussnaxzcjmvi Mclzjsq Clnczwp Gcbrdvnof	Groningen	The Netherlands
Iwjollnhae Zcxpygahyw	Capelle Aan Den Ijssel	The Netherlands
Aixzicmzg Udx	Amsterdam	The Netherlands
Sepvmflwc Rmnhxqh Umvxmhpcyi Menrplt Cxjloe	Nijmegen	The Netherlands
Exbhlev Uyqhwysysfqc Mganlwo Cyjqrxf Rdutdlaql (zejrcnb Myp	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	10.06.2024

Trial locations

Investigated drugs:

Hepatic Arterial Infusion PUMP Chemotherapy is a treatment method where chemotherapy drugs are delivered directly into the liver through a pump. This approach targets liver tumors more directly, potentially increasing the concentration of the drug in the liver while reducing exposure to the rest of the body. It is used in this trial to see if it can improve outcomes for patients with liver metastases from colorectal cancer.

Systemic Therapy involves the use of chemotherapy drugs that travel through the bloodstream to reach cancer cells throughout the body. This is a standard treatment for colorectal cancer that has spread to the liver. The trial compares the effectiveness of systemic therapy alone versus when it is combined with the hepatic arterial infusion pump chemotherapy.

Investigated diseases:

Colorectal Liver Metastases – This condition occurs when cancer cells from the colon or rectum spread to the liver. It is a common site for metastasis due to the blood flow from the intestines to the liver. The disease often progresses silently, with symptoms appearing only when the liver is significantly affected. Patients may experience abdominal pain, weight loss, or jaundice as the disease advances. The progression can vary, with some cases remaining stable for a period, while others may rapidly worsen. The liver’s function can be compromised as the metastases grow, impacting overall health.

Trial ID:

2023-506194-35-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Floxuridine and Drug Combination for Patients with Unresectable Colorectal Liver Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?