Clinical trial · Interventional
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.
- 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)
Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| bevacizumab, erlotinib | Drug | — | UNRESOLVED |
| low dose capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- bevacizumab and erlotinib (KRAS WT)
- interventionNames
- Drug: bevacizumab, erlotinib
- type
- ACTIVE_COMPARATOR
- label
- bevacizumab (KRAS WT)
- interventionNames
- Drug: bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- bevacizumab (KRAS mutated)
- interventionNames
- Drug: bevacizumab
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Untreated metastatic colorectal carcinoma * Age 18 yrs or over * Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria) * ECOG performance status 0 or 1 * Life expectancy more than 3 months * Adequate haematological, renal and liver function * Tumor tissue available for determination of KRAS mutational status * Blood sample and paraffin embedded tumor tissue for translational research Exclusion Criteria: * Adjuvant therapy within 6 months * CNS metastases * Clinically significant atherosclerotic vascular disease
References
Publications (1)
- DERIVEDHagman H, Frodin JE, Berglund A, Sundberg J, Vestermark LW, Albertsson M, Fernebro E, Johnsson A. A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trial. Ann Oncol. 2016 Jan;27(1):140-7. doi: 10.1093/annonc/mdv490. Epub 2015 Oct 19. PMID 26483047