Venous Thromboembolism in Advanced Gastric Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01047618
First received: January 12, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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
Advanced Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients : Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the significant impact of VTE on overall survival and in this population [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 259
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Thromboembolism

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047618

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

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01047618     History of Changes
Other Study ID Numbers: AMC-ONCGI-0904
Study First Received: January 12, 2010
Last Updated: August 5, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
venous thromboembolism

Additional relevant MeSH terms:
Stomach Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 25, 2014