An Observational Study of Avastin (Bevacizumab) in Combination With 5-FU-Based Chemotherapy as First-Line Treatment in Chinese Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Observational Study of Avastin Plus 5-FU Based Chemotherapy as First Line Treatment for Chinese Patients With Metastatic Colorectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319877
• Other study ID #: ML25391
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: March 1, 2016
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with 5-Fluorouracil based chemotherapy as first-line therapy in Chinese patients with metastatic colorectal cancer. Data will be collected from each patient for up to 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		36 months	No
Secondary	Overall response rate (according to RECIST criteria)		36 months	No
Secondary	Progression-free survival		36 months	No
Secondary	One-year progression-free survival rate		1 year	No
Secondary	One-year survival rate		1 year	No
Secondary	Correlation between KRAS status and clinical outcome (response/progression-free survival/survival)		36 months	No
Secondary	Effect of chemotherapy regimens on clinical outcome (response/progression-free survival/survival)		36 months	No
Secondary	Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-CR29 questionnaires		up to 36 months	No