A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Clinical chemo-drugs


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chemotherapy<br>Eligible patients will accept generalized chemotherapy according to the investigator's assessment. | Drug: Clinical chemo-drugs<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemotherapy regimen | To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | 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 | 2 months | 
| quality of life | To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice | 6 weeks | 
| treatment expense | To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Gastric Cancer, chemotherapy, quality of life, treatment expense, patients accepted first-line chemotherapy