Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT01811108
• Lead Sponsor: Hellenic Oncology Research Group

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 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.

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 curative liver resection after the administration of treatment, progression free survival and estimation of overall survival

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with AE	Every 2 weeks up to 12 weeks	In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Response Rate	Disease evaluation at Week 6	In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks
Percentage of Patients with Progression Free Survival	1 year
Patients Overall Survival	1 year

Trial Locations

Locations (6)

"IASO" General Hospital of Athens; 🇬🇷 Athens, Greece

University Hospital of Crete, Dep of Medical Oncology; 🇬🇷 Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece