Clinical trial · Interventional
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
Study of Cetuximab in Combination With Chemotherapy for the First Treatment of Metastatic Colorectal Cancer
NCT01564810CI-TRIAL-00008326unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, the investigators assessed the effect of Cetuximab in combination with chemotherapy in the treatment of unresectable metastatic colorectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| chemotherapy of mFOLFOX6 or FOLFIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- patients received cetuximab in combination with chemotherapy
- interventionNames
- Drug: Cetuximab
- Drug: chemotherapy of mFOLFOX6 or FOLFIRI
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Patients received chemotherapy (mFOLFOX6 or FOLFIRI) alone. mFOLFOX6 (day 1, oxaliplatin 85 mg/m², folinic acid 400 mg/m², and fluorouracil 400 mg/m² intravenous bolus, then 2400 mg/m² over 46 h continuous infusion) FOLFIRI (day 1, irinotecan 180mg/m2, folinic acid 400 mg/m², and fluorouracil 400 mg/m² intravenous bolus, then continuous infusion for 46 hours of 2400 mg/m2).
- interventionNames
- Drug: chemotherapy of mFOLFOX6 or FOLFIRI
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years; 2. Primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma; 3. Together with clinical or radiological evidence of first occurrence of non-resectable synchronous liver-only metastases 4. With evidence of tumor EGFR expression and KRAS gene wild-type status; 5. With one measurable tumor. 6. Performance status (ECOG) 0\~1 7. A life expectancy of ≥ 3 months 8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization) 9. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization); 10. Written informed consent for participation in the trial. Exclusion Criteria: 1. Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases. 2. Known or suspected extrahepatic metastases. 3. Patients with known hypersensitivity reactions to any of the components of the study treatments. 4. Having previously participated in a study which included a possibility of being allocated to cetuximab therapy (whether or not the patient actually received cetuximab) 5. Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal 6. Acute or sub-acute intestinal occlusion 7. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding 8. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix 9. Known drug abuse/ alcohol abuse 10. Legal incapacity or limited legal capacity 11. Pre-existing peripheral neuropathy.
References
Publications (1)
- DERIVEDYe LC, Liu TS, Ren L, Wei Y, Zhu DX, Zai SY, Ye QH, Yu Y, Xu B, Qin XY, Xu J. Randomized controlled trial of cetuximab plus chemotherapy for patients with KRAS wild-type unresectable colorectal liver-limited metastases. J Clin Oncol. 2013 Jun 1;31(16):1931-8. doi: 10.1200/JCO.2012.44.8308. Epub 2013 Apr 8. PMID 23569301