Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 882
- 试验地点
- 22
- 主要终点
- Median Progression-free Survival (PFS)
研究概览
简要总结
This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.
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
- •Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label
排除标准
- •History of serious or unexpected reaction to fluoropyrimidine therapy
- •Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
- •Known dihydropyrimidine dehydrogenase deficiency
- •Pregnancy or lactation
- •Inadequate bone marrow, hepatic or renal function
- •Treatment with sorivudine or its chemical analogues (for example, brivudine)
- •If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
研究组 & 干预措施
Metastatic Colorectal Carcinoma (mCRC) Participants
Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed. The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also do not specify any treatment regimen.
干预措施: Capecitabine (Drug)
Metastatic Colorectal Carcinoma (mCRC) Participants
Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed. The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also do not specify any treatment regimen.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Median Progression-free Survival (PFS)
时间窗: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.
PFS by Therapeutic Regimens
时间窗: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.
次要结局
- Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1(Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254)
- Percentage of Participants With Dose Modification of Capecitabine(Baseline up to 1254 days)
- Percentage of Participants Who Underwent Metastasectomy(Baseline up to 1254 days)
- Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1(Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254)
- Mean Duration of Capecitabine Therapy(Baseline up to 1254 days)