Actively Recruiting

Age: 18Years +
All Genders
NCT07114627

Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients

Led by Erasmus Medical Center · Updated on 2025-08-11

66

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this study, the drug capecitabine is investigated. Capecitabine is commonly used to treat breast, colon, and stomach cancers. Capecitabine is taken in tablet form. In the body, capecitabine is converted into the active molecule that has anti-cancer effects. This molecule is called 5-FU. The transformation of capecitabine to 5-FU occurs through specific proteins in the liver, also known as enzymes. Unfortunately, capecitabine can also cause side effects. One of the most common side effects is hand-foot syndrome. In hand-foot syndrome, the palms of the hands and soles of the feet become red and painful. Previous research has shown that patients in whom one of the enzymes responsible for converting capecitabine in the liver does not function properly experience an increase in side effects frequency, particularly severe hand-foot syndrome. This specific enzyme is called CES1. It is believed that side effects occur more frequently because capecitabine is transformed more slowly, eventually leading to a prolonged exposure to 5-FU in the body. In roughly one in three people, this enzyme functions less efficiently. To gain a better understanding of how this mechanism works, we aim to conduct this study. In this study, we will examine if patients with a less effective CES1 enzyme have higher amounts of 5-FU in their blood. We will also look into whether these patients develop side effects, such as hand-foot syndrome, more frequently. This information could eventually help us develop new strategies to reduce side effects for these patients in the future.

CONDITIONS

Official Title

Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Planned to start treatment with concomitant capecitabine and oxaliplatin according to standard of care (any dose)
  • Fit for treatment with capecitabine and oxaliplatin as judged by the treating physician
  • Able to understand and comply with protocol requirements and provide informed consent
Not Eligible

You will not qualify if you...

  • Carrier of a known clinically relevant DPYD variant (*2A, *7, *13, c.1236G>A or c.2846A>T)
  • Medical conditions known to affect capecitabine absorption (Roux-en-Y gastric bypass or complete gastric resection; esophagectomy allowed)
  • Prior treatment with fluoropyrimidines
  • Use of DPD-inhibitors and/or allopurinol
  • Known pregnancy at baseline

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Erasmus MC Cancer Institute

Rotterdam, Netherlands, 3015GD

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients | DecenTrialz