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

NCT ID: NCT02583659

Last Updated: 2015-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Combined chemotherapy

AGC patients treated with first-line combined chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xianglin Yuan

Professor, Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xianglin Yuan, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xianglin Yuan, MD,PHD

Role: CONTACT

13667241722

Suxian Wei, MD

Role: CONTACT

15927421058

Facility Contacts

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Xianglin Yuan, MD,PHD

Role: primary

13667241722 ext. 1

Suxian Wei, Master

Role: backup

15927421058 ext. 1

Other Identifiers

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TJCC004

Identifier Type: -

Identifier Source: org_study_id

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