Study Comparing Trifluridine/Tipiracil with Panitumumab or Bevacizumab for Patients with Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness of treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study will compare two different treatment combinations. The first combination includes the medications trifluridine and tipiracil, which are taken as film-coated tablets, along with panitumumab, which is given as an infusion into a vein. The second combination involves the same tablets, trifluridine and tipiracil, but paired with bevacizumab, another medication administered through an infusion.

The purpose of this study is to determine which combination of treatments is more effective as a first-line treatment for patients with metastatic colorectal cancer. Participants in the study will be randomly assigned to receive one of the two treatment combinations. The study will be conducted over a period of six months, during which participants will receive their assigned treatments and be monitored for their response to the therapy. The study aims to gather information on how well the cancer responds to the treatments, as well as the overall survival and progression-free survival of the participants.

Throughout the study, participants will undergo regular assessments, including imaging tests like MRI or computed tomography (CT) scans, to evaluate the size and spread of the cancer. The study will also monitor the quality of life of participants using a questionnaire and track any side effects experienced during the treatment. The goal is to identify which treatment combination offers the best outcomes for patients with metastatic colorectal cancer.

1 randomization

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will receive either trifluridine/tipiracil plus panitumumab or trifluridine/tipiracil plus bevacizumab as your treatment.

2 treatment administration

If you are in the group receiving trifluridine/tipiracil plus panitumumab, you will take Lonsurf tablets orally. The dosage will be determined by your healthcare provider. Panitumumab will be administered through an intravenous infusion, which means it will be given directly into your vein.

If you are in the group receiving trifluridine/tipiracil plus bevacizumab, you will also take Lonsurf tablets orally. Bevacizumab will be administered through an intravenous infusion.

3 treatment cycle

The treatment will be given in cycles. Each cycle typically lasts for a few weeks, during which you will receive the medications as prescribed by your healthcare provider. The exact schedule and duration will be explained to you by the medical team.

4 monitoring and assessments

Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This may include physical exams, blood tests, and imaging studies like CT or MRI scans.

Your healthcare team will also monitor for any side effects or adverse reactions to the medications.

5 follow-up

After completing the treatment cycles, follow-up visits will be scheduled to continue monitoring your health and the effects of the treatment. These visits are important to assess the long-term outcomes and any potential late side effects.

Who Can Join the Study?

Patient must provide a signed informed consent.
Patients not on blood thinners must have specific blood test results: INR (a blood clotting test) less than 1.5 times the normal limit and PTT (another blood clotting test) less than 1.5 times the normal limit. Patients on blood thinners can participate if their medication dose is stable for at least 2 weeks before starting the study and their INR and PTT are within the required limits.
Women who can have children must have a negative pregnancy test within 14 days before starting the study and agree to avoid pregnancy by using reliable birth control methods or abstaining from sex during the study and for at least 6 months after the last dose of study treatment.
Men must agree to avoid fathering a child by using birth control methods or abstaining from sex during the study and for 6 months after the last dose of study treatment. They must also agree not to donate sperm during this time.
Patients must be 18 years or older at the time of signing the informed consent.
Patients must have a confirmed diagnosis of adenocarcinoma of the colon or rectum. Cancer of the appendix is not included.
Patients must have metastatic colorectal cancer with at least one measurable tumor as seen on a CT (computed tomography) or MRI (magnetic resonance imaging) scan done within 5 weeks before starting the study.
The cancer must be primarily not removable by surgery, or the patient is unable or unwilling to have surgery.
Patients must have a specific type of cancer called RAS wild-type, confirmed by a validated test.
Patients must not be eligible for combination chemotherapy or must be unwilling to undergo it, as assessed by the study doctor.
Patients must have an ECOG performance status of 0 to 2, which is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Patients must have adequate bone marrow, liver, and kidney function, as shown by specific laboratory test results:

Absolute neutrophil count (a type of white blood cell) of at least 1.5 x 10⁹/L.
Hemoglobin (a protein in red blood cells) of at least 80 g/L.
Platelet count (cells that help with blood clotting) of at least 75 x 10⁹/L without transfusion.
Total serum bilirubin (a liver function test) of 1.5 times the normal limit or less.
AST and ALT (liver enzymes) of 2.5 times the normal limit or less, or 5 times the normal limit if liver abnormalities are due to liver metastasis.
Calculated GFR (a kidney function test) of at least 30 mL/min or serum creatinine (another kidney function test) of 1.5 times the normal limit or less.
Urine test for protein must show less than 2+ protein, or a 24-hour urine collection must show less than 1 gram of protein in 24 hours.

Who Cannot Join the Study?

Patients with any other type of cancer besides metastatic colorectal cancer cannot participate.
Patients who have had another cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems, such as a recent heart attack or heart failure, cannot join the study.
Patients with uncontrolled high blood pressure are not allowed to participate.
Patients with active infections that require treatment with antibiotics are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with known allergies to the study drugs or similar medications are not eligible.
Patients who have participated in another clinical trial within the last 30 days are not allowed to join.
Patients with a history of drug or alcohol abuse within the past year are excluded.
Patients with any other serious medical condition that might interfere with the study are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitätsklinikum Freiburg	Freiburg Im Breisgau	Germany
ÜBAG MVZ Dr. Vehling-Kaiser GmbH Dingolfing	Dingolfing	Germany

Other Sites

Site Name	City	Country
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Johannes Wesling Klinikum Minden	Minden	Germany
Klinikum St Marien Amberg	Amberg	Germany
Klinikum Magdeburg gGmbH	Magdeburg	Germany
Staedtisches Klinikum Dessau	Dessau-Roßlau	Germany
Krankenhaus Maria Hilf GmbH	Krefeld	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Ludwig Maximilian University Of Munich	Munich	Germany
Dr. Vehling-Kaiser MVZ GmbH	Landshut	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt	Germany
Charite Research Organisation GmbH	Berlin	Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH	Bamberg	Germany
Studienzentrum Onkologie Ravensburg GmbH	Ravensburg	Germany
MVM Medizinische Verwaltungs und Managementgesellschaft mbH	Leer (ostfriesland)	Germany
Romed Klinikum Rosenheim	Rosenheim	Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm	Berlin	Germany
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg	Aschaffenburg	Germany
Onkologische Praxis	Wangen im Allgäu	Germany
Klinik Esslingen GmbH, Klinik für Innere Medizin, Hämatologie ,Onkologie u. Gastroenterologie	Esslingen Am Neckar	Germany
Klinikum München-Bogenhausen	Munich	Germany
MVZ Onkologie im Klinikum Bayreuth GmbH	Bayreuth	Germany
Usdotcpaloisujenziyac Atyhiqmb	Augsburg	Germany
Flozmegewanoaqlzlwd Bncldoex	Bruchsal	Germany
Amgzpmsrkxjqodybytmykqu gqbjy	Bochum	Germany
Bktgaidetsoiujjts Srf Juojn Ptzoninza	Paderborn	Germany
Kitpmdlc ddo Sbixt Kgidx grwjf	Cologne	Germany
Ovqtbvikppxn Sbaqgijshdwrjetuk iq Mhsfuzgyr	Hildesheim	Germany
Unjqmlefltgpastlqckql Djsmnoyhefp Aoj	Duesseldorf	Germany
Kyfmrtvm Bjmniyhg Gtgi	Bayreuth	Germany
Kmkcgqft Espmhrwlqcozfjvyqulidejx Hbrewjuvaqfncomfc	Essen	Germany
Pmddpb ag Vschcejef	Berlin	Germany
Mecumil Kdttdo Nbngzjohnn	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	21.12.2021

Trial locations

Investigated drugs:

Trifluridine/Tipiracil is a combination medication used in this trial to treat metastatic colorectal cancer. It works by interfering with the DNA of cancer cells, which helps to stop their growth and spread. This medication is taken orally and is designed to target cancer cells specifically, aiming to slow down the progression of the disease.

Panitumumab is a type of targeted therapy known as a monoclonal antibody. It works by attaching to a specific protein on the surface of cancer cells, which can help to stop the cells from growing and dividing. In this trial, it is used in combination with Trifluridine/Tipiracil to enhance the treatment’s effectiveness against colorectal cancer.

Bevacizumab is another targeted therapy used in this trial. It is also a monoclonal antibody, but it works differently from Panitumumab. Bevacizumab targets a protein that helps cancer cells form new blood vessels, which they need to grow. By blocking this protein, Bevacizumab can help to starve the cancer cells, slowing their growth and spread. It is used alongside Trifluridine/Tipiracil in this study to improve treatment outcomes for patients with metastatic colorectal cancer.

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and spread through the lymphatic system or bloodstream to distant organs. The disease often progresses in stages, starting from localized tumors to regional spread, and eventually to distant metastasis. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-513723-16-00

Protocol code:

FIRE-8

NCT ID:

NCT05007132

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Trifluridine/Tipiracil with Panitumumab or Bevacizumab for Patients with Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?