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NCT Number: NCT01811108

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Crete, Dep of Medical Oncology, Heraklion, Crete, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants with AE

    Time frame: 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 outcomes

  1. Number of Participants with Response Rate

    Time frame: 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

  2. Percentage of Patients with Progression Free Survival

    Time frame: 1 year

  3. Patients Overall Survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2013
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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