Clinical trial NCT01811108: Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: mCRC
KRAS mutation
Chemotherapy
Anti-angiogenic agent
Bevacizumab
1st Line
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Clinics for cancer prevention

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

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

Primary outcomes:
measure: Number of Participants with AE
timeFrame: Every 2 weeks up to 12 weeks
Secondary outcomes:
measure: Number of Participants with Response Rate
timeFrame: Disease evaluation at Week 6
measure: Percentage of Patients with Progression Free Survival
timeFrame: 1 year
measure: Patients Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dept. of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Study officials:
affiliation: Hellenic Oncology Research Group
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: