The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study

• Conditions: Gastric Cancer

• Registration Number: NCT02583659
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

1. Establish a clinical database for the advanced gastric cancer patients treated with first-line combined chemotherapy in Tongji hospital.

1.1.Data including age, gender, smoking state, karnofsky performance score（KPS）, disease history, clinical stage, primary tumor site, metastasis site, surgery, first-line chemotherapy, therapy after failure of first-line treatment, radiotherapy, toxicity, survival time, the time of free of progress, response were collected.

1.2.The peripheral blood samples were collected for further biomarker reserch.

2. Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer.

3. Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11
• Primary Completion: 2016-06
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
2. Unresectable locally advanced, or recurrent, or metastasis disease；
3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
4. Life expectancy of at least 3 months;
5. ECOG score 0-2;
6. Voluntarily signed the informed consent.

Exclusion criteria:

1. Previously treated with first-line chemotherapy;
2. First-line chemotherapy with single drug.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Through first-line treatment completion,up to 24 weeks.
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

Trial Locations

Locations (1)

Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China