Venous Thromboembolism in Advanced Gastric Cancer Patients
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ClinicalTrials.gov Identifier: NCT01047618 |
Recruitment Status
:
Completed
First Posted
: January 13, 2010
Last Update Posted
: June 26, 2015
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Condition or disease |
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Advanced Gastric Cancer |
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 Type : | Observational |
Actual Enrollment : | 259 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients : Prospective Observational Study |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Group/Cohort |
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Thromboembolism |
- 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 ]
- To investigate the significant impact of VTE on overall survival and in this population [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047618
Korea, Republic of | |
Asan Medical Center, University of Ulsan College of Medicine | |
Seoul, Korea, Republic of, 138-736 |
Principal Investigator: | Yoon-Koo Kang, MD,PhD | Asan Medical Center | |
Principal Investigator: | Baek-Yeol Ryoo, MD,PhD | Asan Medical Center | |
Principal Investigator: | Min-Hee Ryu, MD,PhD | Asan Medical Center |
Responsible Party: | Yoon-Koo Kang, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01047618 History of Changes |
Other Study ID Numbers: |
AMC-ONCGI-0904 |
First Posted: | January 13, 2010 Key Record Dates |
Last Update Posted: | June 26, 2015 |
Last Verified: | June 2015 |
Keywords provided by Yoon-Koo Kang, Asan Medical Center:
venous thromboembolism |
Additional relevant MeSH terms:
Stomach Neoplasms Thromboembolism Venous Thromboembolism Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |