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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583659
• Other study ID #: TJCC004
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2015
• Last updated: November 10, 2015
• Start date: January 2013
• Est. completion date: January 2018

Study information

• Verified date: October 2015
• Source: Huazhong University of Science and Technology
• Contact: Xianglin Yuan, MD,PHD
• Phone: 13667241722
• Email: yxl[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei Province
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		Through first-line treatment completion,up to 24 weeks.	Yes