Clinical trial · Interventional
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated 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)
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic 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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cediranib | Drug | Cediranib | ALIAS |
| Cediranib Placebo | Drug | — | UNRESOLVED |
| FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) | Drug | FOLFOX Regimen | ALIAS |
| XELOX (Capecitabine and Oxaliplatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- FOLFOX + placebo Cediranib
- description
- FOLFOX + placebo Cediranib
- interventionNames
- Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Drug: Cediranib Placebo
- type
- PLACEBO_COMPARATOR
- label
- Xelox + placebo Cediranib
- description
- Xelox + placebo Cediranib
- interventionNames
- Drug: XELOX (Capecitabine and Oxaliplatin)
- Drug: Cediranib Placebo
- type
- EXPERIMENTAL
- label
- FOLFOX + Cediranib
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Written Informed Consent * Carcinoma of the colon or rectum * One or more measurable lesions Exclusion Criteria: * Adjuvant/neoadjuvant therapy within 6-12 months of study entry * Untreated unstable brain or meningeal metastases * Specific laboratory ranges * Specific cardiovascular problems * Participation in other trials within 30 days
References
Publications (1)
- DERIVEDSmith JC, Brooks L, Hoff PM, McWalter G, Dearden S, Morgan SR, Wilson D, Robertson JD, Jurgensmeier JM. KRAS mutations are associated with inferior clinical outcome in patients with metastatic colorectal cancer, but are not predictive for benefit with cediranib. Eur J Cancer. 2013 Jul;49(10):2424-32. doi: 10.1016/j.ejca.2013.02.023. Epub 2013 Mar 16. PMID 23510802