Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 268
- 试验地点
- 37
- 主要终点
- Progression Free Survival (PFS) Rate at 12 Months
研究概览
简要总结
The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.
Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.
This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.
Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically proven adenocarcinoma of the colon or the rectum
- •Metastatic disease not amenable to potentially curative treatment
排除标准
- •Prior therapy for metastatic cancer of the colon or the rectum
- •Prior treatment with angiogenesis inhibitors
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
mFOLFOX6 only
modified FOLFOX6 chemotherapy regimen
干预措施: oxaliplatin (Drug)
mFOLFOX6 only
modified FOLFOX6 chemotherapy regimen
干预措施: 5-FU (Drug)
mFOLFOX6 only
modified FOLFOX6 chemotherapy regimen
干预措施: Folinic Acid (Drug)
mFOLFOX6 + aflibercept
modified FOLFOX6 chemotherapy regimen in combination with aflibercept
干预措施: aflibercept (Drug)
mFOLFOX6 + aflibercept
modified FOLFOX6 chemotherapy regimen in combination with aflibercept
干预措施: oxaliplatin (Drug)
mFOLFOX6 + aflibercept
modified FOLFOX6 chemotherapy regimen in combination with aflibercept
干预措施: 5-FU (Drug)
mFOLFOX6 + aflibercept
modified FOLFOX6 chemotherapy regimen in combination with aflibercept
干预措施: Folinic Acid (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Rate at 12 Months
时间窗: 12 months
PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAE)(From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized)
- Immunogenicity of Intravenous (IV) Aflibercept(Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status)
- Overall Objective Response Rate (ORR)(From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months))
- Overall Survival (OS)(From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months))
- Progression Free Survival (PFS)(From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months))