drugset / Trial / NCT01918527
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |