Venous Thromboembolism in Advanced Gastric Cancer Patients

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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 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.

Condition or disease
Advanced Gastric Cancer

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

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Thromboembolism

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. To investigate the significant impact of VTE on overall survival and in this population [ Time Frame: 2 years ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Population

All patients of advanced gastric cancer with palliative chemotherapy

Criteria

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

• Serious illness or medical conditions, as follows:

  1. Congestive heart failure (NYHA class III or IV)
  2. Unstable angina or myocardial infarction within the past 12 months
  3. Significant arrhythmia requiring medication and conduction abnormality such as over 2nd degree AV block
  4. Uncontrolled hypertension
  5. Liver cirrhosis (≥ Child class B)
  6. Psychiatric disorder that may interfere with protocol compliance
  7. Unstable diabetes mellitus
  8. 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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736

Sponsors and Collaborators

Asan Medical Center

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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