Clinical trial NCT01319877: An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
Official title: A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with metastatic colorectal cancer receiving first-line therapy with Bevacizumab in combination with 5-FU-based chemotherapy

Brief summary: This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.


Eligibility criteria: Inclusion Criteria:

* Adult Chinese participants, \>/= 18 years of age
* Histologically confirmed and previously untreated metastatic colorectal cancer
* Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
* Documented participant 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: 36 months
measure: Percentage of Participants With Serious Adverse Events
timeFrame: 36 months
measure: Percentage of Participants With Adverse Events of Special Interest
timeFrame: 36 months
measure: Percentage of Participants With Bevacizumab-Related Adverse Events
timeFrame: 36 months
measure: Percentage of Participants With Bevacizumab-related Serious Adverse Events
timeFrame: 36 months
Secondary outcomes:
measure: Percentage of Participants Achieving an Overall Response
timeFrame: 36 months
measure: Progression-free Survival
timeFrame: 36 months
measure: One-year Progression-free Survival Rate
timeFrame: 1 year
measure: One-year Survival Rate
timeFrame: 1 year
measure: Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
timeFrame: 36 months
measure: One-year Progression-free Survival Rate Per KRAS Subgroup
timeFrame: 1 year
measure: One-year Survival Rate by the KRAS Subgroup
timeFrame: 1 year
measure: Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
timeFrame: Up to 36 Months
measure: One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
timeFrame: 1 year
measure: One-year Survival Rate by the Chemotherapy Regimen Subgroup
timeFrame: 1 year
measure: Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
timeFrame: Up to 36 Months
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Changzhou
country: China
city: Chengdu
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Nanjing
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Shenyang
country: China
city: Wuhan
country: China
city: Xi'an
country: China
city: Xiamen
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: