- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811108
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer
October 23, 2014 updated by: Hellenic Oncology Research Group
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.
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
670
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandroupolis, Greece
- University General Hospital of Alexandroupolis, Dept. of Medical Oncology
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Athens, Greece
- Air Forces Military Hospital of Athens
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Athens, Greece
- "IASO" General Hospital of Athens
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Piraeus, Greece
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Thessaloniki, Greece
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Crete
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Heraklion, Crete, Greece
- University Hospital of Crete, Dep of Medical Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Clinics for cancer prevention
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
Cohorts and Interventions
Group / Cohort |
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Avastin regimens
Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with AE
Time Frame: Every 2 weeks up to 12 weeks
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In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.
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Every 2 weeks up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Response Rate
Time Frame: Disease evaluation at Week 6
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In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks
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Disease evaluation at Week 6
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Percentage of Patients with Progression Free Survival
Time Frame: 1 year
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1 year
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Patients Overall Survival
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vassilis Georgoulias, MD, Hellenic Oncology Research Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 21, 2013
First Submitted That Met QC Criteria
March 12, 2013
First Posted (Estimate)
March 14, 2013
Study Record Updates
Last Update Posted (Estimate)
October 24, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT/10.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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