Monitoring of treatment with bevacizumab in patients with metastatic colorectal cancer

ISRCTN	ISRCTN59241668
DOI	https://doi.org/10.1186/ISRCTN59241668
Secondary identifying numbers	71/12/07

Submission date: 13/08/2010
Registration date: 27/09/2010
Last edited: 27/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Janja Ocvirk
Scientific

Zaloska cesta 2
Ljubljana
1000
Slovenia

Study information

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
Study setting(s)	Not specified
Study type	Screening
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Monitoring of treatment with bevacizumab in patients with metastatic colorectal cancer: a single centre observational study
Study objectives	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(s)	The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia approved on the 11th December 2007 (ref: 71/12/07)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	31/12/2007
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	400
Key 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
Key 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
Date of first enrolment	31/12/2007
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Slovenia

Study participating centre

Zaloska cesta 2

Ljubljana
1000
Slovenia

Sponsor information

Institute Of Oncology Ljubljana (Slovenia)
Research organisation

Zaloska cesta 2
Ljubljana
1000
Slovenia

"ROR"	https://ror.org/00y5zsg21

Funders

Funder type

Research organisation

Institute of Oncology Ljubljana (Slovenia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan