Monitoring of treatment with bevacizumab in patients with metastatic colorectal cancer
| ISRCTN | ISRCTN59241668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59241668 |
| Protocol serial number | 71/12/07 |
| Sponsor | Institute Of Oncology Ljubljana (Slovenia) |
| Funder | Institute of Oncology Ljubljana (Slovenia) |
- 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
Scientific
Zaloska cesta 2
Ljubljana
1000
Slovenia
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational study, retrospective to December 2007 and prospective from December 2007 onwards |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Safety of treatment with bevacizumab |
| Key secondary outcome measure(s) |
1. Progression- free survival (PFS) |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
1000
Slovenia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
