Clinical trial NCT01912443: Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Proswell Medical Corporation
First posted: 2013-07-31
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed metastatic colorectal cancer are eligible

Brief summary: To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

Detailed description: This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.

Eligibility criteria: Inclusion Criteria:

* with histologically confirmed metastatic colorectal cancer
* patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment
* Written informed consent
* Unlimited line of treatment (first-line or second line is not limited)

Exclusion Criteria:

Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:

* Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood
* Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours \*

  * The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours.
* Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds
* Pregnant or lactating women
* Excluding patients known to be allergic to bevacizumab or any of the excipients

Primary outcomes:
measure: Incidence, nature and severity of adverse events of special interest
timeFrame: Four years
measure: Incidence, nature and severity of bevacizumab related serious adverse events
timeFrame: Four years
measure: Onset time of adverse event associated with bevacizumab
timeFrame: Four years
measure: Laboratory parameters
timeFrame: Four years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Four years
measure: Overall response rate (ORR) of treatment line
timeFrame: Four years
measure: Progression-free survival (PFS) of treatment line:
timeFrame: Four years
measure: One-year disease-free progression rate of treatment line
timeFrame: One year
measure: One-year survival rate of treatment line
timeFrame: One year
measure: Overall survival (OS) of treatment line
timeFrame: Four years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shenyang
country: China
facility: Liaoning Cancer Hosptial & Institute
state: Liaoning
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuan
city: Beijing
country: China
facility: First Affiliated Hospital of PLA General Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: