Fluoropyrimidine Dose-Adjustment for Colorectal Cancer

This trial tests ways to safely adjust the dosage of certain cancer drugs, such as Fluorouracil and Xeloda, for people with colorectal cancer. The researchers aim to determine if patients with a specific genetic variant (DPYD) experience fewer severe side effects with lower doses compared to the standard dose. Individuals diagnosed with cancer who require treatment with these drugs and have a genetic test showing one DPYD variant might be suitable for this trial. Participants will receive either a reduced dose or the standard dose to compare outcomes. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment can benefit more patients.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Studies have shown that adjusting the dose of fluorouracil can lower the risk of severe side effects in patients with colorectal cancer. Patients might experience fewer issues like nausea, vomiting, or mouth sores when their dose is carefully managed. Research indicates that higher amounts of fluorouracil can lead to more harmful effects, so precise dosing is crucial for safety.

For Xeloda, also known as capecitabine, safety information comes from studies involving over 3,000 patients. This research shows that the drug is generally safe but can cause side effects like diarrhea, nausea, and hand-foot syndrome, which causes redness and swelling in the hands and feet. Adjusting the dose can help manage these side effects, especially in individuals with kidney problems.

Researchers are excited about this trial because it explores how adjusting the doses of fluoropyrimidine treatments, like Fluorouracil and Xeloda, based on genetic differences can improve safety for colorectal cancer patients. Unlike traditional approaches where everyone receives the same dose, this trial examines if patients with a specific genetic variant (DPYD heterozygotes) can safely receive lower doses, reducing the risk of severe side effects. This personalized approach could lead to more effective and safer treatments, tailoring therapy to each patient's genetic makeup and potentially setting a new standard for colorectal cancer treatment.

This trial will compare dose adjustments of fluorouracil (5-FU) and Xeloda (capecitabine) for colorectal cancer based on genetic variations. Research has shown that adjusting the dose of fluorouracil according to individual patient needs can enhance safety and effectiveness. Studies have found that customizing the dosage can lead to better treatment outcomes and fewer side effects. Similarly, Xeloda, a chemotherapy pill, effectively manages colorectal cancer. Even when the dose is lowered to reduce side effects, it remains effective in controlling disease progression. Both treatments have proven effective in colorectal cancer care, especially with careful dose management. Participants in this trial will be assigned to different arms based on their genetic profile to evaluate these dose adjustments.¹⁵⁶⁷⁸