A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.
Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100142
- Lin Shen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
- The informed consent form is signed.
- A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
- ECOG performance status is 0, 1 or 2.
- The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
- The patient is aged≥18
Exclusion Criteria:
- The patient is known to be allergic to any study drug.
- The patient is recruited in other clinical study or is planned to participate into other clinical study.
- The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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chemotherapy
Eligible patients will accept generalized chemotherapy according to the investigator's assessment.
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Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below: Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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chemotherapy regimen
大体时间：2 months
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To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China
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2 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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overall survival
大体时间：2 months
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OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost
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2 months
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quality of life
大体时间：6 weeks
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To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice
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6 weeks
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treatment expense
大体时间：2 months
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To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice
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2 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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