drugset / Trial / NCT01918527

Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

NCT01918527 ↗

Phase 3 Active not recruiting 250 enrolled Vejle Hospital
RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy. Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.

Timeline

Start
2013-09
Primary completion
2023-06
Completion
2026-06

Outcome

Missed primary endpoint

paper At 3 years, DFS was 87% in the upfront surgery arm and 83% in the neoadjuvant arm (P = .36). PMID 41779406 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications