Clinical trial · Interventional
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
NCT00286130CI-TRIAL-00006822completedPhase 2ClinicalTrials.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 Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan | Drug | — | UNRESOLVED |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX 6 | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX 6
- description
- FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
- interventionNames
- Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
- Drug: FOLFOX 6
- type
- ACTIVE_COMPARATOR
- label
- FOLFIRI
- description
- FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
- interventionNames
- Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
- Drug: FOLFIRI
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * Metastatic colorectal carcinoma not suitable for curative-intent resection * Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment * Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area) * ECOG performance status of \< 2 at study entry Exclusion Criteria: * Brain metastasis (known or suspected) * Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months * Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry * Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Any investigational agent(s) within 4 weeks prior to entry * Previous exposure to EGFR-pathway targeting therapy
References
Publications (0)
Data not yet available
No reference posted for this study.