Study comparing trifluridine/tipiracil with bevacizumab versus capecitabine with bevacizumab as first-line treatment for patients with metastatic colorectal cancer who cannot receive intensive therapy

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What is this study about?

This study focuses on patients with metastatic colorectal cancer who cannot receive intensive therapy. The research compares two different treatment combinations. The first combination includes trifluridine/tipiracil with bevacizumab, while the second combines capecitabine with bevacizumab. Metastatic colorectal cancer occurs when cancer that starts in the colon or rectum spreads to other parts of the body.

The main purpose of this study is to determine if the combination of trifluridine/tipiracil with bevacizumab works better than capecitabine with bevacizumab as a first treatment option. The medications are given in different ways – some are taken as tablets by mouth, while bevacizumab is given through an intravenous line (directly into a vein).

During the study, doctors will monitor how the disease responds to treatment and track any side effects that may occur. They will also evaluate how the treatments affect patients’ overall health and quality of life. The study is “open-label,” which means both doctors and patients know which treatment is being given.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups for your metastatic colorectal cancer

Both groups receive bevacizumab through intravenous infusion

Group 1 receives trifluridine/tipiracil (Lonsurf) tablets by mouth

Group 2 receives capecitabine (Xeloda) tablets by mouth

2 Treatment administration

You will receive regular doses of the assigned medications

Bevacizumab is given through an intravenous infusion at the treatment center

The tablets (either Lonsurf or Xeloda) are taken at home according to the prescribed schedule

Treatment continues until your condition shows progression or you experience unacceptable side effects

3 Regular monitoring

Your doctor will perform regular physical examinations

Laboratory tests will check your blood counts and organ function

Heart monitoring through ECG (heart rhythm test) will be conducted

Your overall health status will be assessed using the ECOG scale (a measure of daily living abilities)

Imaging scans will track how your cancer responds to treatment

4 Quality of life assessment

You will complete questionnaires about your well-being and daily activities

Any side effects or health changes will be recorded and monitored

5 Study completion

The study continues until June 2025

Your participation ends if your disease progresses or you experience unacceptable side effects

A final evaluation will be conducted when your participation ends

Who Can Join the Study?

  • Must have confirmed adenocarcinoma (a type of cancer that starts in gland cells) of the colon or rectum, with known location of the primary tumor
  • Must have RAS status (a genetic test that helps determine treatment options) from tumor testing available or have tissue sample available for testing
  • Not suitable for standard full-dose combination chemotherapy with irinotecan or oxaliplatin (types of chemotherapy drugs)
  • Cannot have cancer that can be removed through surgery
  • No previous cancer treatments for metastatic colorectal cancer (cancer that has spread to other parts of the body)
  • Must have an ECOG performance status of 2 or less (a scale that measures a patient’s ability to perform daily activities, where 0 is fully active and 2 means able to do light activities but unable to work)
  • Must have adequate organ function, including:
    • Proper kidney function
    • Normal blood cell counts
    • Adequate liver function
    • Normal blood clotting
  • Both men and women may participate
  • Must be an adult (18 years or older)

Who Cannot Join the Study?

  • Prior chemotherapy for metastatic colorectal cancer (cancer that has spread to other parts of the body)
  • History of bevacizumab (a cancer treatment medication) intolerance or allergic reactions
  • Active brain metastases (cancer that has spread to the brain)
  • Severe heart conditions in the past 6 months, including:
    • Heart attack
    • Unstable chest pain
    • Severe heart rhythm problems
  • Uncontrolled high blood pressure (above 150/90 mmHg despite medication)
  • Major surgery within 28 days before starting the study
  • Active bleeding or high risk of bleeding
  • Serious infections requiring antibiotics
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Other active cancers in the past 5 years (except for adequately treated skin cancer or cervical cancer)
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Severe kidney or liver problems
  • Any condition that, in the doctor’s opinion, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o. Tomaszow Mazowiecki Poland
Region Joenkoepings Laen Jönköping Sweden
Region Midtjylland Aarhus Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.03.2019
Poland Poland
Not recruiting
01.03.2019
Slovakia Slovakia
Not recruiting
01.03.2019
Sweden Sweden
Not recruiting
01.03.2019

Trial locations

Trifluridine/tipiracil (S 95005) is a combination medication used to treat colorectal cancer. It works by interfering with cancer cell growth and division. This medication is taken orally and helps slow down the progression of cancer in patients who have metastatic colorectal cancer.

Bevacizumab is a targeted therapy medication that works by blocking the formation of new blood vessels that feed tumors. By preventing the growth of these blood vessels, it helps slow down or stop cancer growth. It is given through an intravenous (IV) infusion.

Capecitabine is an oral chemotherapy medication that converts to an active form inside cancer cells. It works by interfering with cancer cell DNA production and growth. This medication is commonly used to treat various types of cancer, including colorectal cancer.

Investigated diseases:

Metastatic colorectal cancer – A condition that begins as cancer in the colon or rectum and spreads to other parts of the body. The disease starts when cells in the large intestine begin to grow uncontrollably and form tumors. These cancer cells can break away from the original tumor and travel through the blood or lymph system to form new tumors in other organs. It most commonly spreads to the liver, but can also affect the lungs, bones, and other organs. The disease typically develops gradually over time, starting as small growths called polyps in the inner lining of the colon or rectum, which can eventually become cancerous and spread beyond the original site.

Trial ID:
2024-516180-85-00
Protocol code:
CL3-95005-006
NCT ID:
NCT03869892
Trial Phase:
Therapeutic confirmatory (Phase III)

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