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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02583659

Enrollment

250

Registered

2015-10-22

Start date

2013-01-31

Completion date

2018-01-31

Last updated

2015-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric cancer, First-line chemotherapy, Biomarker

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

China

Contacts

Primary ContactXianglin Yuan, MD,PHD

yxl@medmail.com.cn13667241722

Backup ContactSuxian Wei, MD

wsxattj@126.com15927421058

Outcome results