drugset / Trial / NCT01500993

Capecitabine in the Perioperative Treatment of Rectal Cancer

NCT01500993 ↗

Phase 3 Completed 401 enrolled University Medical Center Mannheim
RandomizedParallel-groupOpen-labelTreatment

Summary

This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer.

Timeline

Start
2002-03
Primary completion
2011-03
Completion
2011-03

Outcome

Met primary endpoint

paper 5-year overall survival in the capecitabine group was non-inferior to that in the fluorouracil group PMID 22503032 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1650 mg/m2 Oral
Subject Capecitabine Small molecule 2500 mg/m2 Oral
Comparator fluorouracil Small molecule 225 mg/m2 —
Comparator fluorouracil Small molecule 500 mg/m2 —
Comparator fluorouracil Small molecule 1000 mg/m2 —

Indications