The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
1 other identifier
observational
250
1 country
1
Brief Summary
This prospective cohort study aims to observe the efficacy and safety of the first-line combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedNovember 11, 2015
October 1, 2015
3.4 years
October 19, 2015
November 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival(OS) . overall survival Overall survival(OS)
From date of enrollment until the date of death from any cause, assessed up to 60 months
Secondary Outcomes (4)
Progression-free survival(PFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Objective response rate(ORR)
The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first-line treatment completion, up to 1 year
Disease control rate(DCR)
The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Through first-line treatment completion,up to 24 weeks.
Study Arms (1)
Combined chemotherapy
AGC patients treated with first-line combined chemotherapy
Eligibility Criteria
Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotheapy-naive gastric cancer and gastroesophageal adenocarcinoma patients
You may qualify if:
- Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- Unresectable locally advanced, or recurrent, or metastasis disease；
- Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
- Life expectancy of at least 3 months;
- ECOG score 0-2;
- Voluntarily signed the informed consent.
You may not qualify if:
- Previously treated with first-line chemotherapy;
- First-line chemotherapy with single drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Biospecimen
DNA extracted from peripheral blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xianglin Yuan, MD,PHD
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chief Physician
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 22, 2015
Study Start
January 1, 2013
Primary Completion
June 1, 2016
Study Completion
January 1, 2018
Last Updated
November 11, 2015
Record last verified: 2015-10