Advanced Gastric CancerNCT01047618
Venous Thromboembolism in Advanced Gastric Cancer Patients
An observational study of Advanced Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis (DVT), is a common complication and leading cause of death in cancer patients. Large, population-based studies have shown that patients with cancer have four- to seven-fold increased risk of developing VTE compared with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Cancer
- How many people
- 259 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of advanced gastric cancer with palliative chemotherapy
Who may be able to join
- Histologically documented gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
- Age 18 years or older
- Locally advanced (inoperable) or metastatic gastric cancer, initially diagnosed, recurrent gastric cancer
- Performance status (ECOG scale) : 0-2
- Adequate bone marrow function:
- Adequate renal function
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- Adequate hepatic function:
- Required to be at the start of a new chemotherapy regimen
- Received chemotherapy one cycle or more
- Adequate follow-up for at least 12 weeks
- Patients should sign a written informed consent before study entry
Who cannot join
- Previously exposed to chemotherapy exception adjuvant or neoadjuvant therapy
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
- Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
- Presence of CNS metastasis
- Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery. Patient received curative operation or RFA for metastatic disease.
- Significant traumatic injury within 4 weeks prior to enrollment
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- Serious illness or medical conditions, as follows:
- Congestive heart failure (NYHA class III or IV)
- Unstable angina or myocardial infarction within the past 12 months
- Significant arrhythmia requiring medication and conduction abnormality such as over 2nd degree AV block
- Uncontrolled hypertension
- Liver cirrhosis (≥ Child class B)
- Psychiatric disorder that may interfere with protocol compliance
- Unstable diabetes mellitus
- Active infection
- Superficial thrombophlebitis, transient ischemic attacks, and thrombosis occurring in setting of disseminated intravascular coagulation
- Pregnant or lactating women
- Hormonal replacement therapy within 4 weeks
- Chronic oral treatment with corticosteroid unless initiated > 6 months prior to study entry and at low dose (≤ 20mg methylprednisolone or equivalent)
- Warfarin of heparin therapy
- Not able or willing to give informed consent
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients: Prospective Observational Study
Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis (DVT), is a common complication and leading cause of death in cancer patients. Large, population-based studies have shown that patients with cancer have four- to seven-fold increased risk of developing VTE compared with patients without cancer. VTE would be frequent in patients with advanced gastric cancer, especially associated chemotherapy. However, relatively few studies have been conducted regarding the incidence of VTE in Asian cancer patients. According to previous review, Asian patients significantly lower risk of developing VTE. The rate of VTE with advanced gastric cancer, and associated chemotherapy is not known in Asian patients. In addition, the impact of VTE on overall survival has not been documented in these patients.
Read the detailed description
Primary objectives - To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population
Secondary objectives
- To investigate the significant impact of VTE on overall survival and in this population
- Conditions
- Advanced Gastric Cancer
- Keywords
- venous thromboembolism
- Medical subject headings
- Venous Thromboembolism
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 |
|---|---|---|
| Thromboembolism | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population
Measured: 2 years
Secondary outcomes (1)
To investigate the significant impact of VTE on overall survival and in this population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2014
- Study completionDec 2014
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 Asan Medical CenterThe 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
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Koo Kang, Asan Medical Center
- Investigators
- Yoon-Koo Kang, MD,PhD, Principal investigator, Asan Medical CenterBaek-Yeol Ryoo, MD,PhD, Principal investigator, Asan Medical CenterMin-Hee Ryu, MD,PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047618
- Sponsor's protocol ID
- AMC0904
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2010
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01047618
- Acronym / sponsor ID
- AMC0904
- Conditions
- Advanced Gastric Cancer
- Keywords
- venous thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jan 2010 (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.
Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis (DVT), is a common complication and leading cause of death in cancer patients. Large, population-based studies have shown that patients with cancer have four- to seven-fold increased risk of developing VTE compared with patients without cancer. VTE would be frequent in patients with advanced gastric cancer, especially associated chemotherapy. However, relatively few studies have been conducted regarding the incidence of VTE in Asian cancer patients. According to previous review, Asian patients significantly lower risk of developing VTE. The rate of VTE with advanced gastric cancer, and associated chemotherapy is not known in Asian patients. In addition, the impact of VTE on overall survival has not been documented in these patients.
Detailed description
Primary objectives - To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population
Secondary objectives
- To investigate the significant impact of VTE on overall survival and in this population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thromboembolism | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of advanced gastric cancer with palliative chemotherapy
Key inclusion criteria (11 listed)
- Histologically documented gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
- Age 18 years or older
- Locally advanced (inoperable) or metastatic gastric cancer, initially diagnosed, recurrent gastric cancer
- Performance status (ECOG scale) : 0-2
- Adequate bone marrow function:
Key exclusion criteria (22 listed)
- Previously exposed to chemotherapy exception adjuvant or neoadjuvant therapy
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
- Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
- Presence of CNS metastasis
- Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery. Patient received curative operation or RFA for metastatic disease.
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
To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population
Time frame: 2 years
1 secondary outcome
To investigate the significant impact of VTE on overall survival and in this population
Time frame: 2 years
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 7 Jan 2020.
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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.
Yoon-Koo Kang, MD,PhD principal investigator
Asan Medical Center
Baek-Yeol Ryoo, MD,PhD principal investigator
Asan Medical Center
Min-Hee Ryu, MD,PhD principal investigator
Asan Medical Center
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 Asan Medical Center at 1 site in South Korea.
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 11 inclusion and 22 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 7 Jan 2020. 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 South Korea. 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?
To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population (time frame: 2 years). 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 7 Jan 2020.