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The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients : Prospective Observational Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Gastric Cancer

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Trial Information

The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients : Prospective Observational Study


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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Yoon-Koo Kang, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Institutional Review Board

Study ID:

AMC0904

NCT ID:

NCT01047618

Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Advanced Gastric Cancer
  • venous thromboembolism
  • Stomach Neoplasms
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

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