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

NCT ID: NCT01811108

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 670 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-12-31

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

Conditions

Metastatic Colorectal Cancer

Study Design

• Observational Model Type: COHORT

Study Groups

Avastin regimens

Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vassilis Georgoulias, MD

Role: PRINCIPAL_INVESTIGATOR

Hellenic Oncology Research Group

Locations

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, , Greece

"IASO" General Hospital of Athens

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, , Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/10.12

Identifier Type: -

Identifier Source: org_study_id