Clinical trial NCT02583659: The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
Official title: The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Gastric cancer
First-line chemotherapy
Biomarker
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival(OS) . overall survival Overall survival(OS)
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 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
measure: Objective response rate(ORR)
timeFrame: 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
measure: Disease control rate(DCR)
timeFrame: 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
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Through first-line treatment completion,up to 24 weeks.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xianglin Yuan, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: