drugset
drugset / Trial / NCT04389086

Induction Chemotherapy for Locally Recurrent Rectal Cancer

NCT04389086 ↗

Phase 3 Recruiting 364 enrolled Catharina Ziekenhuis Eindhoven
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Timeline

Start
2020-11-13
Primary completion
2024-03-01
Completion
2030-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

rectal cancer