Abstrakt: |
A clinical trial, NCT06475352, is being conducted by UNICANCER to establish guidelines for reducing the dose of fluoropyrimidine in patients with DPD deficiency who are undergoing treatment for gastrointestinal cancers. The trial aims to determine the appropriate reduction dose of fluoropyrimidine for these patients. Participants will receive the treatment with the reduced dose as specified by the protocol and will visit the clinic regularly for checkups and adverse event monitoring. The trial will assess the proportion of grade ≥3 haematological and gastrointestinal toxicity induced by fluoropyrimidine, as well as other secondary outcome measures such as recommended dose, fluoropyrimidine toxicity, disease-free survival, overall survival, and progression-free survival. The trial is not yet recruiting and is expected to enroll 400 participants, with a completion date of October 2029. The eligibility criteria for participation in the trial are also provided. [Extracted from the article] |