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

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ClinicalTrials.gov Identifier: NCT01811108
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group

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.

Condition or disease
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

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Study Type : Observational
Actual Enrollment : 670 participants
Observational Model: Cohort
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 Start Date : July 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort
Avastin regimens
Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Clinics for cancer prevention
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811108


Locations
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Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, 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
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
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Principal Investigator: Vassilis Georgoulias, MD Hellenic Oncology Research Group

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Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01811108     History of Changes
Other Study ID Numbers: CT/10.12
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Keywords provided by Hellenic Oncology Research Group:
mCRC
KRAS mutation
Chemotherapy
Anti-angiogenic agent
Bevacizumab
1st Line
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors