NCT02673710已完成不适用
A Multicenter Non-Interventional Study Exploring the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With a Chemotherapy Combined With Bevacizumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 23
- 主要终点
- Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first
研究概览
简要总结
The purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond PD
- •Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
- •Availability of specific retrospective data at diagnosis and during 1st line treatment
排除标准
- •Patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition
- •Dementia or another mental condition making it impossible to fill out questionnaires
结局指标
主要结局
Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first
时间窗: Up to 3 years
Sarcopenia quantified via CT-scan defined as a skeletal muscle index at the 3rd lumbar vertebra below 41 for women and below 43 or 53 for men with a Body Mass Index below or above 25 respectively
时间窗: Up to 3 years
次要结局
- Participants body mass index at initial diagnosis of mCRC(Up to 3 years)
- Participants skeletal muscle mass at initial diagnosis of mCRC(Up to 3 years)
- Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE(Up to 3 years)
- Participants Eastern Cooperative Oncology Group Performance status at SE(Up to 3 years)
- Participant muscle strength at initial diagnosis of mCRC(Up to 3 years)
- Participants primary and metastases location at Initial Diagnosis(Up to 3 years)
- Participants mutation status at Initial Diagnosis(Up to 3 years)
- Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis(Up to 3 years)
- Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis(Up to 3 years)
- Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis(Up to 3 years)
- Participants body weight at initial diagnosis of mCRC(Up to 3 years)
- Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants(Up to 3 years)
- Participant Physical status expressed in muscle strength(Up to 3 years)
- Participant Physical status expressed in Body Weight(Up to 3 years)
- Participant Physical status expressed in Body Mass Index(Up to 3 years)
- Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire(Up to 3 years)
- Nutritional status using Visual Analogue Scale for appetite(Up to 3 years)
- Treatment related toxicity using MD Anderson Symptom Inventory scale(Up to 3 years)
- Number of participants with Number of chemotherapy cycles(Up to 3 years)
- Number of participants with Number of bevacizumab administrations(Up to 3 years)
- Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease(Up to 3 years)
- Number of participants with Reason for treatment changes(Up to 3 years)
- Intake dietary supplements(Up to 3 years)
- Dietary and physical counselling(Up to 3 years)
- Number of Participants with Adverse Events(Up to 3 years)
- First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease(Up to 3 years)
研究者
研究点 (23)
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