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Capecitabine metronomic chemotherapy for metastatic colorectal cancer patients reaching NED: A protocol for a prospective, randomized, controlled trial

Introduction

More patients with metastatic colorectal cancer (mCRC) are now showing no signs of disease after treatment. However, current guidelines don’t clearly recommend ongoing treatment for these patients. Capecitabine metronomic chemotherapy is a promising option due to its effectiveness and low side effects, yet no randomized controlled trials (RCTs) have been done on this approach. This trial aims to assess the safety and effectiveness of capecitabine for these patients.

Study Design

This study will involve 240 patients with stage IV mCRC who have undergone complete removal of their tumors and showed no evidence of disease. Participants will be randomly divided into two groups: one will receive capecitabine for two years, while the other will only have regular check-ups without additional treatment. All patients will be monitored for one year after the treatment period.

Outcomes Measured

The main goal of the study is to evaluate disease-free survival (DFS). We will gather data based on factors such as previous chemotherapy and the extent of disease at diagnosis. Secondary goals include overall survival rates and tracking any side effects from the treatment.

Importance of the Trial

This trial is crucial as it will help determine whether low-dose capecitabine metronomic chemotherapy is a viable treatment for mCRC patients who have reached no evidence of disease. Positive results could lead to better management strategies in clinical settings.

Taking Action

Clinics can set measurable goals based on the outcomes of this trial and adopt capecitabine metronomic chemotherapy where appropriate. Utilizing AI tools tailored for healthcare can enhance the tracking and analysis of treatment results.

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