Improving the safety of fluoropyrimidine-based chemotherapy by combined DPYD genotype-guided and DPD phenotype-guided dose individualisation: The Alpe2U study

• Conditions: Cancer (breast cancer; colorectal cancer; gastric cancer); 10027656

• Registration Number: NL-OMON49970
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 1440

Inclusion Criteria

1. Pathologically confirmed malignancy for which treatment with a
fluoropyrimidine is considered to be in the patient*s best interest
2. Patient need to be of Western descent
3. Age >= 18
4. Able and willing to give written informed consent
5. WHO performance status of 0, 1 or 2
6. Able and willing to undergo extra blood sampling for study related analysis
7. Adequate baseline patient characteristics (complete blood count, hepatic
function which involves serum bilirubin, AST, ALT, and renal function)

Exclusion Criteria

1. Prior treatment with fluoropyrimidines
2. Patients with known substance abuse, psychotic disorders, and/or other
diseases expected to interfere with study or the patient*s safety
3. Patients treated with the combination of a fluoropyrimidine and irinotecan

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint in this study is the incidence of severe treatment-related<br /><br>toxicity (NCI CTC-AE grade 3 to 5) in DPYD wildtype patients treated with a<br /><br>reduced dose based on DPD phenotype compared to DPYD wildtype patients treated<br /><br>with a full dose of fluoropyrimidines after 2 cycles, based on uracil<br /><br>concentration.</p><br>