drugset
drugset / Trial / NCT04495088

Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

NCT04495088 ↗

Phase 3 Recruiting 550 enrolled Ralf Hofheinz Deutsche Krebshilfe e.V., Bonn (Germany) · collabGerman Rectal Cancer Study Group · collabInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure

Timeline

Start
2020-09-30
Primary completion
2030-08
Completion
2030-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Capecitabine Small molecule 1250 mg/m2 Oral
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Leucovorin Small molecule 500 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 600 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2600 mg/m2 Intravenous

Indications

rectal cancer