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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01811108

Enrollment

670

Registered

2013-03-14

Start date

2009-07-31

Completion date

2013-12-31

Last updated

2014-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

mCRC, KRAS mutation, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line

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

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Greece

Outcome results