Gastric CancerNCT02583659
The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
An observational study of Gastric Cancer, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotheapy-naive gastric cancer and gastroesophageal adenocarcinoma patients
Who may be able to join
- Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- Unresectable locally advanced, or recurrent, or metastasis disease；
- Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
- Life expectancy of at least 3 months;
- ECOG score 0-2;
- Voluntarily signed the informed consent.
Who cannot join
- Previously treated with first-line chemotherapy;
- First-line chemotherapy with single drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xianglin Yuan, MD,PHD, 13667241722 ext. 1, yxl@medmail.com.cn
Suxian Wei, Master, 15927421058 ext. 1, wsxattj@126.com
About this study
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.
Read the detailed description
- 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.
- Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer.
- Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, First-line chemotherapy, Biomarker
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Combined chemotherapy | AGC patients treated with first-line combined chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS) . overall survival Overall survival(OS)
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
Secondary outcomes (4)
Progression-free survival(PFS)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Through first-line treatment completion,up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2016 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
- Investigators
- Xianglin Yuan, MD,PHD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583659
- Sponsor's protocol ID
- TJCC004
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT02583659
- Acronym / sponsor ID
- TJCC004
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, First-line chemotherapy, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer.
- Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined chemotherapy | – | –AGC patients treated with first-line combined chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotheapy-naive gastric cancer and gastroesophageal adenocarcinoma patients
Key inclusion criteria (6 listed)
- Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- Unresectable locally advanced, or recurrent, or metastasis disease；
- Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
- Life expectancy of at least 3 months;
- ECOG score 0-2;
Key exclusion criteria (2 listed)
- Previously treated with first-line chemotherapy;
- First-line chemotherapy with single drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianglin Yuan, MD,PHD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianglin Yuan, MD,PHD (13667241722, yxl@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.