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

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Clinical chemo-drugs

• Registration Number: NCT01472250
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-11
• Study First Posted: 2011-11-16
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

1. 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.
2. The informed consent form is signed.
3. A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
4. ECOG performance status is 0, 1 or 2.
5. The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
6. The patient is aged≥18

Exclusion Criteria

1. The patient is known to be allergic to any study drug.
2. The patient is recruited in other clinical study or is planned to participate into other clinical study.
3. 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chemotherapy	Clinical chemo-drugs	Eligible patients will accept generalized chemotherapy according to the investigator's assessment.

Primary Outcome Measures

Name	Time	Method
chemotherapy regimen	2 months	To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lin Shen; 🇨🇳 Beijing, Beijing, China