Colorectal Cancer Clinical Trial
Official title:
Capecitabine Metronomic Chemotherapy Versus Conventional Chemotherapy as Maintenance Treatment in Metastatic Colorectal Cancer
The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus conventional chemotherapy.
In this Prospective, open-label, randomised controlled trial, the investigators will recruit
250 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease
evaluation is SD, PR or CR. Then, the patients will be randomised into two group. The
experimental group, capecitabine metronomic chemotherapy versus capecitabine conventional
chemotherapy as control group. These treatment regimens will be continued until progression,
death, or an unacceptable adverse event.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall
survival (OS), quality of life (QOL) and toxic effects.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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