Clinical trial · Observational
Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG
NCT01243372CI-TRIAL-00046163completedClinicalTrials.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)
RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Correlative (BRAF V600E mutation analysis)
- description
- Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.
- interventionNames
- Genetic: mutation analysis
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Progression-free survival as measured by RECIST
- timeFrame
- Up to 36 months
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- Up to 36 months
- measure
- tumor response as measured by RECIST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Participation in CALGB-C80405
* Have KRAS WT or KRAS mut tumor
* Randomized to treatment with either bevacizumab or cetuximab alone
* Patients randomized to the combination therapy are not eligible
* Available specimens at the PCO for BRAF mutation detection
* Patient consent for use of samplesReferences
Publications (0)
Data not yet available
No reference posted for this study.