Clinical trial · Observational
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) Retrospectively (From 1/7/2009) and Prospectively (up to 31/12/2013) as First Line Treatment for Patients With Locally Advanced or Metastatic Colorectal Cancer (With or Without KRAS Mutation). Assessment of Toxicity, Compliance and Survival of Patients.
- 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)
Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with 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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Avastin regimens
- description
- Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)
Primary outcomes (1)
- measure
- Number of Participants with AE
- timeFrame
- Every 2 weeks up to 12 weeks
- description
- In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.
Secondary outcomes (3)
- measure
- Number of Participants with Response Rate
- timeFrame
- Disease evaluation at Week 6
- description
- In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Histologically confirmed metastatic or locally advanced non-operable colorectal cancer * No prior first line treatment for metastatic colorectal cancer * Age ≥18 years * One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria * ECOG performance status ≤2 * Adequate haematological, renal and hepatic function * Urine protein \<2+ (dipstick) * Life expectancy of ≥12 weeks Exclusion Criteria: * Previous first line treatment for metastatic colorectal cancer(progression \>6 months after the end of adjuvant treatment) * Previous radiotherapy to target lesions * Patients with brain metastases and/or cancerous meningitis * Metastatic infiltration \>50% of the liver parenchyma * Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma * Patients participating in interventional clinical trial
References
Publications (0)
Data not yet available