An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 719
- 试验地点
- 42
- 主要终点
- Percentage of Participants with Serious Adverse Events (SAEs)
研究概览
简要总结
This prospective, multi-center, observational study will assess the safety and efficacy of Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving Avastin in combination with a standard of care first-line chemotherapy regimen. Data will be collected for 1.5 years or until death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic colorectal cancer with no previous systemic treatment for advanced disease
- •Receiving Avastin in combination with a first-line standard of care chemotherapy regimen
- •Avastin initiated at the same time as first-line chemotherapy regimen
排除标准
- •Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
- •Contraindication to Avastin
研究组 & 干预措施
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
干预措施: Bevacizumab (Drug)
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
干预措施: Capecitabine/Oxaliplatin (Drug)
Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
干预措施: Bevacizumab (Drug)
Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
干预措施: Fluorouracil/Folinic Acid/Oxaliplatin (Drug)
Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
干预措施: Bevacizumab (Drug)
Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
干预措施: Capecitabine (Drug)
Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
干预措施: Bevacizumab (Drug)
Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
干预措施: Fluorouracil/Folinic Acid/Irinotecan (Drug)
Bevacizumab and Capecitabine/Irinotecan
Participants who receive bevacizumab in combination with capecitabine/irinotecan
干预措施: Bevacizumab (Drug)
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
干预措施: Bevacizumab (Drug)
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
干预措施: Fluorouracil +/- Folinic Acid (Drug)
Other
Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants with Serious Adverse Events (SAEs)
时间窗: 1.5 years
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires new in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
Percentage of Participants with Grade 3-5 Avastin Related Adverse Events
时间窗: 1.5 years
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. Adverse events were graded according to NCI-CTCAE, v4.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0).
Progression-Free Survival
时间窗: 1.5 years
Progression-Free Survival (PFS) was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. PFS was assessed using Kaplan-Meier method.
Overall Survival
时间窗: 1.5 years
Overall Survival (OS) is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause.
次要结局
- Percentage of Participants with Avastin Related Adverse Events of Special Interest(1.5 years)
- Reasons for Discontinuation of Avastin(1.5 years)
- Median Progression Free Survival from Four Avastin Studies(1.5 years (ACORN))
- Median Overall Survival from Four Avastin Studies(1.5 years (ACORN))
- Percentage of Participants with Comparative AEs from Four Avastin® Studies(1.5 years (ACORN))
- Median Age of Participants in Four Avastin® Studies(Baseline)
- Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies(Baseline)
- Percentage of Males and Females in Four Avastin Studies(Baseline)
- Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies(1.5 years (ACORN))
- Race/Ethnicity of Participants in Four Avastin Studies(Baseline)
- Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies(Baseline)
- Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies(Baseline)
- Sites of CRC in Four Avastin Studies(Baseline)
- Percentage of Participants with Primary Resection in Four Avastin Studies(Baseline)
- Metastatic Sites of CRC in Four Avastin Studies(Baseline)
- Ongoing Patient Medical Conditions in Four Avastin Studies(Baseline)
- Weeks of Further Treatment After 1st Line Chemotherapy(From disease progression until end of study.)
- Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: In the last three months how many times have you seen health care professionals at your GP Surgery or day centre?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: What was your employment status before diagnosis?(Baseline)
- Response to the Burden of Illness Question: What is your employment status now?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)
- Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support?(Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy)