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.
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
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.
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
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort
Outcome Measure:
Number of Participants with AE
Outcome Description:
In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.
Outcome Time Frame:
Every 2 weeks up to 12 weeks
Safety Issue:
Yes
Principal Investigator
Vassilis Georgoulias, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hellenic Oncology Research Group
Authority:
Greece: National Organization of Medicines
Study ID:
CT/10.12
NCT ID:
NCT01811108
Start Date:
July 2009
Completion Date:
December 2013
Related Keywords:
- Metastatic Colorectal Cancer
- mCRC
- KRAS mutation
- Chemotherapy
- Anti-angiogenic agent
- Bevacizumab
- 1st Line
- Colorectal Neoplasms
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