Clinical trial · Observational
An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
NCT01134666CI-TRIAL-00028057terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued due to slow recruitment and subjects not completing follow up period.
Summary
Brief summary (as posted)
This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and tolerability evaluated based on the incidence and severity of AEs.
- timeFrame
- From baseline to follow-up visit for any ongoing AEs
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- Baseline to End-of-Study Visit
- description
- Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC) * Subjects with KRAS wild-type status of tumour tissue * Chemotherapy naïve subjects * Subject who have signed written informed consent (as per institutional protocol) Exclusion Criteria: * As per summary of product characteristics of cetuximab
References
Publications (0)
Data not yet available
No reference posted for this study.