Observational Study of Avastin Plus 5-FU Based Chemotherapy as First Line Treatment for Chinese Patients With Metastatic Colorectal Cancer.
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Observational Study of Avastin Plus 5-FU Based Chemotherapy as First Line Treatment for Chinese Patients With Metastatic Colorectal Cancer.
Inclusion Criteria:
- Adult Chinese patients, >/= 18 years of age
- Histologically confirmed and previously untreated metastatic colorectal cancer
- Initiated on treatment with Avastin (in combination with 5-FU based chemotherapy)
according to locally approved Avastin China package insert
- Documented patient with medical records
Exclusion Criteria:
- Recent history of serious hemorrhage or hemoptysis of >/= 1/2 teaspoon of red blood
- Proteinuria at baseline (>/=2 grams / 24 hours)
- Major surgical procedure within 28 days prior to study treatment start, not fully
healed wounds
- Pregnant or lactating women
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety: Incidence of adverse events
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
China: Food and Drug Administration
Study ID:
ML25391
NCT ID:
NCT01319877
Start Date:
March 2011
Completion Date:
December 2014
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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