Advanced Gastric CancerNCT01472250
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
An observational study of Advanced Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Clinical chemo-drugs
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jul 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with advanced gastric cancer
Who may be able to join
- The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
- The informed consent form is signed.
- A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
- ECOG performance status is 0, 1 or 2.
- The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
- The patient is aged≥18
Who cannot join
- The patient is known to be allergic to any study drug.
- The patient is recruited in other clinical study or is planned to participate into other clinical study.
- The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.
Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Clinical chemo-drugs
- Keywords
- Advanced Gastric Cancer, chemotherapy, quality of life, treatment expense, patients accepted first-line chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical chemo-drugsDrug
Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below:
Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Receives: Drug: Clinical chemo-drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemotherapy regimen
To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China
Measured: 2 months
Secondary outcomes (3)
overall survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost
Measured: 2 months
quality of life
To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice
Measured: 6 weeks
treatment expense
To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472250
- Sponsor's protocol ID
- CGOG1002
- Status last verified
- May 2017
- First submitted
- 28 Oct 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
- ClinicalTrials.gov ID
- NCT01472250
- Acronym / sponsor ID
- CGOG1002
- Conditions
- Advanced Gastric Cancer
- Keywords
- Advanced Gastric Cancer, chemotherapy, quality of life, treatment expense, patients accepted first-line chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Nov 2011 (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 is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.
Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | – | Drug: Clinical chemo-drugsEligible patients will accept generalized chemotherapy according to the investigator's assessment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced gastric cancer
Key inclusion criteria (6 listed)
- The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
- The informed consent form is signed.
- A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
- ECOG performance status is 0, 1 or 2.
- The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
Key exclusion criteria (3 listed)
- The patient is known to be allergic to any study drug.
- The patient is recruited in other clinical study or is planned to participate into other clinical study.
- The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical chemo-drugsClinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below: Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel | Drug | chemotherapy |
Primary outcome
chemotherapy regimen
Time frame: 2 months
To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China
3 secondary outcomes
overall survival
Time frame: 2 months
quality of life
Time frame: 6 weeks
treatment expense
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Advanced Gastric Cancer, run by Peking University 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 3 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: finished, as of the sponsor's last update on 9 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chemotherapy regimen (time frame: 2 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 9 May 2017.