Clinical trial · Interventional
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
NCT00469443CI-TRIAL-00003817completedPhase 3ClinicalTrials.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)
This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- FOLFIRI/Avastin
- interventionNames
- Drug: Irinotecan
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- 2
- description
- XELIRI/Avastin
- interventionNames
- Drug: Capecitabine
- Drug: Bevacizumab
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Time To Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed locally advanced or metastatic colorectal cancer * Measurable or evaluable disease * ECOG performance status ≤ 2 * Age 18 - 72 years * Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function * Patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin * Patients must be able to understand the nature of this study * Written informed consent Exclusion Criteria: * Previous 1st line chemotherapy * Adjuvant chemotherapy with Irinotecan regimen with relapse \< 6 months after the completion * Active infection * History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow * Patients with unstable CNS metastases * Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction * Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women * Patients \> 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
References
Publications (1)
- DERIVEDSouglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, Xynogalos S, Christophyllakis Ch, Kouroussis Ch, Vamvakas L, Georgoulias V, Polyzos A. Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC). Br J Cancer. 2012 Jan 31;106(3):453-9. doi: 10.1038/bjc.2011.594. Epub 2012 Jan 12. PMID 22240792