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

Metastatic Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811108
• Other study ID #: CT/10.12
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: October 23, 2014
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with AE	In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks.	Every 2 weeks up to 12 weeks	Yes
Secondary	Number of Participants with Response Rate	In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks	Disease evaluation at Week 6	No
Secondary	Percentage of Patients with Progression Free Survival		1 year	No
Secondary	Patients Overall Survival		1 year	No