Status:
COMPLETED
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 chem...
Detailed Description
In addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. That means percentage of objective responses, duration of response, frequency of cura...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT01811108
Start Date
July 1 2009
End Date
December 1 2013
Last Update
October 24 2014
Active Locations (6)
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1
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
2
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens
Athens, Greece
4
Air Forces Military Hospital of Athens
Athens, Greece