Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
71/12/07
Study information
Scientific title
Monitoring of treatment with bevacizumab in patients with metastatic colorectal cancer: a single centre observational study
Acronym
Study hypothesis
Observational study, recording safety according to the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 3.0 and evaluating efficacy in standard clinical practice.
Ethics approval
The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia approved on the 11th December 2007 (ref: 71/12/07)
Study design
Single centre observational study, retrospective to December 2007 and prospective from December 2007 onwards
Primary study design
Observational
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Metastatic colorectal cancer
Intervention
Non-interventional, observational study.
Patients with metastatic colorectal cancer are treated with standard chemotherapy in combination with bevacizumab as per SmPC. During the treatment adverse events of special interest to bevacizumab (high blood pressure, haemorrhage, thromboembolism, proteinuria, GI perforation, neutropenia, infection etc.) are recorded according the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 3.0.
Assessments are performed at baseline, 3 and 6 months, thereafter follow-up is every 3 months (3 years follow-up).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Safety of treatment with bevacizumab
2. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
3. Rate of radical surgical resection (R0 resection)
Secondary outcome measures
1. Progression- free survival (PFS)
2. Overall survival (OS)
Overall trial start date
31/12/2007
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Written informed consent (for prospective part of the study)
2. Histologically or cytologically confirmed colorectal carcinoma with evidence of metastasis
3. Age 18 - 75 years
4. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2
5. Adequate haematological and organ function
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Clinical evidence of brain metastases
2. Clinically significant cardiovascular disease. Examples:
2.1. Cerebrovascular accident (CVA) less than or equal to 6 months before treatment start
2.2. Myocardial infarction less than or equal to 6 months before treatment start
2.3. Unstable angina
2.4. New York Heart Association (NYHA) greater than or equal to grade 2 chronic heart failure (CHF)
2.5. Arrhythmia requiring medication
2.6. Uncontrolled hypertension
3. Current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes
4. History of thromboembolic or haemorrhagic events within 6 months prior to treatment
5. Evidence of bleeding diathesis or coagulopathy
6. Serious, non-healing wound, ulcer, or bone fracture
7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment
8. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of bevacizumab or puts the patient at high risk for treatment-related complications
Recruitment start date
31/12/2007
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Slovenia
Trial participating centre
Zaloska cesta 2
Ljubljana
1000
Slovenia
Funders
Funder type
Research organisation
Funder name
Institute of Oncology Ljubljana (Slovenia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary