Advanced Gastric Cancer Clinical Trial
Official title:
The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients: Prospective Observational Study
NCT number | NCT01047618 |
Other study ID # | AMC0904 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2009 |
Est. completion date | December 2014 |
Verified date | January 2020 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 259 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center, University of Ulsan College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population | 2 years | ||
Secondary | To investigate the significant impact of VTE on overall survival and in this population | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05028933 -
IMC001 for Clinical Research on Advanced Digestive System Malignancies
|
Phase 1 | |
Completed |
NCT00821990 -
Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
|
Phase 3 | |
Recruiting |
NCT04385641 -
Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
|
N/A | |
Completed |
NCT01248403 -
A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy
|
Phase 3 | |
Not yet recruiting |
NCT01206218 -
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT00976768 -
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
|
Phase 2 | |
Completed |
NCT01851941 -
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03223376 -
A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA)
|
Phase 3 | |
Completed |
NCT03609359 -
Lenvatinib and Pembrolizumab Simultaneous Combination Study
|
Phase 2 | |
Completed |
NCT03350477 -
Bioinformation Therapy for Gastric Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT02935634 -
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03579784 -
Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer
|
Phase 2 | |
Completed |
NCT02952729 -
Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2
|
Phase 1 | |
Recruiting |
NCT02072317 -
Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer
|
Phase 2 | |
Terminated |
NCT01402401 -
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients
|
Phase 2 | |
Completed |
NCT01472250 -
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
|
N/A | |
Completed |
NCT01503372 -
FLO +/- Pazopanib as First-line Treatment in Advanced Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT01015339 -
Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
|
Phase 3 | |
Completed |
NCT02071043 -
Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis
|
Phase 2 | |
Completed |
NCT01441336 -
Laparoscopic Gastrectomy for Advanced Gastric Cancer
|
Phase 2 |