Condition category
Cancer
Date applied
13/08/2010
Date assigned
27/09/2010
Last edited
27/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janja Ocvirk

ORCID ID

Contact details

Zaloska cesta 2
Ljubljana
1000
Slovenia

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

Sponsor information

Organisation

Institute Of Oncology Ljubljana (Slovenia)

Sponsor details

Zaloska cesta 2
Ljubljana
1000
Slovenia

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes