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

November 10, 2015 updated by: Xianglin Yuan, Huazhong University of Science and Technology
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Xianglin Yuan, MD,PHD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Suxian Wei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotheapy-naive gastric cancer and gastroesophageal adenocarcinoma patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Combined chemotherapy
AGC patients treated with first-line combined chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival(OS) . overall survival Overall survival(OS)
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
From date of enrollment until the date of death from any cause, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival(PFS)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: Through first-line treatment completion,up to 24 weeks.
Through first-line treatment completion,up to 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Xianglin Yuan, MD,PHD, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJCC004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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