drugset / Trial / NCT00153998
Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)
RandomizedParallel-groupOpen-labelTreatment
Summary
General Objectives: * To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection * To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for further trials in preoperative chemotherapy
Timeline
- Start
- 2004-11
- Primary completion
- 2008-03
- Completion
- —
Publications
- Folprecht G, Gruenberger T, Bechstein W, Raab HR, Weitz J, Lordick F, Hartmann JT, Stoehlmacher-Williams J, Lang H, Trarbach T, Liersch T, Ockert D, Jaeger D, Steger U, Suedhoff T, Rentsch A, Kohne CH. Survival of patients with initially unresectable colorectal liver metastases treated with FOLFOX/cetuximab or FOLFIRI/cetuximab in a multidisciplinary concept (CELIM study). Ann Oncol. 2014 May;25(5):1018-25. doi: 10.1093/annonc/mdu088. Epub 2014 Feb 27.
- Folprecht G, Gruenberger T, Bechstein WO, Raab HR, Lordick F, Hartmann JT, Lang H, Frilling A, Stoehlmacher J, Weitz J, Konopke R, Stroszczynski C, Liersch T, Ockert D, Herrmann T, Goekkurt E, Parisi F, Kohne CH. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet Oncol. 2010 Jan;11(1):38-47. doi: 10.1016/S1470-2045(09)70330-4. Epub 2009 Nov 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 3000 mg/m2 | Intravenous |