Completed

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.

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What is being collected

Data Collection

Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2009
See protocol details

Summary

Principal SponsorHellenic Oncology Research Group
Last updated: October 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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

NCT01811108
Principal SponsorHellenic Oncology Research Group
Last updated: October 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

670 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

9 inclusion criteria required to participate
Adequate haematological, renal and hepatic function
Age >= 18 years
ECOG performance status <= 2
Histologically confirmed metastatic or locally advanced non-operable colorectal cancer
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6 exclusion criteria prevent from participating
Metastatic infiltration > 50% of the liver parenchyma
Patients participating in interventional clinical trial
Patients with brain metastases and/or cancerous meningitis
Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

University Hospital of Crete, Dep of Medical Oncology

Heraklion, GreeceOpen University Hospital of Crete, Dep of Medical Oncology in Google Maps

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

&quot;IASO&quot; General Hospital of Athens

Athens, Greece

Air Forces Military Hospital of Athens

Athens, Greece
Completed6 Study Centers