drugset / Trial / NCT03031444
Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis
Phase 2/3
Completed
135 enrolled
Peking University Cancer Hospital & Institute
Beijing Municipal Administration of Hospitals · collabFirst Affiliated Hospital of Kunming Medical University · collabWest China Hospital · collabZhejiang Cancer Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis. The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.
Timeline
- Start
- 2016-01
- Primary completion
- 2020-12-30
- Completion
- 2020-12-30
Publications
- Background Primrose J, Falk S, Finch-Jones M, Valle J, O'Reilly D, Siriwardena A, Hornbuckle J, Peterson M, Rees M, Iveson T, Hickish T, Butler R, Stanton L, Dixon E, Little L, Bowers M, Pugh S, Garden OJ, Cunningham D, Maughan T, Bridgewater J. Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. Lancet Oncol. 2014 May;15(6):601-11. doi: 10.1016/S1470-2045(14)70105-6. Epub 2014 Apr 7.
- Results Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Comparator | Capecitabine | Small molecule | 850 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 1200 mg/m2 | Intravenous |