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Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (LCAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01980849
Recruitment Status : Unknown
Verified November 2013 by Shengqing Li, Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : November 11, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nadroparin, long term Drug: Nadroparin: short-term Phase 3

Detailed Description:
This is a prospective, multi-center, randomized and controlled study. Advanced lung cancer patients without venous thromboembolism(VTE) are included. The selected patients were randomized into A and B groups. Group A: Nadroparin given during hospitalization, 0.4mL, subcutaneously, qid; Group B: Nadroparin given by long-term, 0.4mL, subcutaneously, qid. The incidence of VTE , the risks of bleeding and overall survival in two groups of patients are studied at different time points.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Long term prophylaxis
Nadroparin, 0.4mL, subcutaneously, qid, given by long-term
Drug: Nadroparin, long term
Active Comparator: Short-term prophylaxis
Nadroparin, 0.4mL, subcutaneously, qid, given during hospitalization
Drug: Nadroparin: short-term


Outcome Measures

Primary Outcome Measures :
  1. Incidence of venous thromboembolism [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Incidence of bleeding [ Time Frame: During 6 months ]

Other Outcome Measures:
  1. Overall survival [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage Ⅲ B and Ⅳ non-small cell lung cancer patients and inoperable small cell lung cancer patients
  • Performance status score ≤ 2
  • Chest CT with measurable lesions

Exclusion Criteria:

  • Examination revealed any part of venous thromboembolism
  • Chemotherapy regimens containing bevacizumab or Endostar
  • Severe coagulopathy
  • Active bleeding within two weeks
Contacts and Locations

Information from the National Library of Medicine

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): NCT01980849


Contacts
Contact: Shengqing Li, MD, PhD +86-29-84771132

Locations
China, Chongqing
The Department of Oncology,Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Zhihua Ruan, MD    13883933815    rzh1234@163.com   
Principal Investigator: Zhihua Ruan, MD         
The Department of Pulmonary and Critical Care Medicine,Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Wei Xiong, MD    13512345225    xiongwei64@126.com   
Principal Investigator: Wei Xiong, MD         
The Department of Oncology,Ohtsubo Hospital Recruiting
Chongqing, Chongqing, China, 400042
Contact: Xueqin Yang, MD    15923366936    yxq92@163.com   
Principal Investigator: Xueqin Yang, MD         
The Department of Oncology,Fuling Central Hospital Recruiting
Chongqing, Chongqing, China, 408000
Contact: Qi Zhou, MD    18996706515    qizhou112@163.com   
Principal Investigator: Qi Zhou, MD         
China, Henan
The Department of Oncology,Central Hospital Recruiting
Xinxiang, Henan, China, 453000
Contact: Guifang Zhang, MD    15637359110    xxchzhangguifang@126.com   
Principal Investigator: Guifang Zhang, MD         
The Department of Oncology,People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Zhifen Luo, MD    13783526222    luozhifen123@126.com   
Principal Investigator: Zhifen Luo, MD         
The Department of Pulmonary and Critical Care Medicine,Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Yanqiu Zhao, MD    13938252350    13938252350@163.com   
Principal Investigator: Yanqiu Zhao, MD         
The Department of Oncology,Henan University Affiliated Yihe Hospital Recruiting
Zhengzhou, Henan, China, 450047
Contact: Yanwei Guo, MD    15238608788    zzymyygyw@163.com   
Principal Investigator: Yanwei Guo, MD         
China, Inner Mongolia
The Department of Oncology,Cancer Hospital Recruiting
Baotou, Inner Mongolia, China, 014030
Contact: Jie Li, MD    13847293318    2469931063@qq.com   
Principal Investigator: Jie Li, MD         
The Department of Oncology,Northern Hospital Recruiting
Baotou, Inner Mongolia, China, 150200
Contact: Fengyun Wang, MD    15047243095    wfy2826@163.com   
Principal Investigator: Fengyun Wang, MD         
The Department of Oncology,Inner Mongolia Autonomous Region Hospital Recruiting
Hohhot, Inner Mongolia, China, 010017
Contact: Cuiying Zhang, MD    13947119586    cenyao_2006@126.com   
Principal Investigator: Cuiying Zhang, MD         
China, Ningxia
The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital Recruiting
Yinchuan, Ningxia, China, 750002
Contact: Mei Yin, MD    13014292909    dmeiyin@163.com   
Principal Investigator: Mei Yin, MD         
China, Shaanxi
The Department of Pulmonary and Critical Care Medicine,Central Hospital Recruiting
Baoji, Shaanxi, China, 721008
Contact: Zhengxia Wu, MD    13891731289    Wzx1289@163.com   
Principal Investigator: Zhengxia Wu, MD         
The Department of Pulmonary and Critical Care Medicine,Second People's Hospital Recruiting
Xi'an, Shaanxi, China, 710005
Contact: Zhangqin Chen, MD    18991211556    1191846052@qq.com   
Principal Investigator: Zhangqin Chen, MD         
The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Manxiang Li, MD, PhD    15129312682    Manxiangli@hotmail.com   
Principal Investigator: Manxiang Li, MD, PhD         
The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yonghong Xie, MD, PhD    +86-29-84777725    xieyh65@yahoo.com.cn   
Principal Investigator: Yonghong Xie, MD, PhD         
The Department of Pulmonary and Critical Care Medicine, Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Xuemin Yang, MD    +86-29-84775237    yangxuemin0622@163.com   
Sub-Investigator: Xuemin Yang, MD         
The Department of Oncology,First Affiliated Hospital of Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yu Yao, MD    13572101611    13572101611@163.com   
Principal Investigator: Yu Yao, MD         
The Department of Oncology,Yan'an University Hospital Recruiting
Yan'an, Shaanxi, China, 716000
Contact: Hong Zhao, MD    18809111001    YDFYzhaohon@163.com   
Principal Investigator: Hong Zhao, MD         
China, Shanxi
The Department of Oncology,Second Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China, 030001
Contact: Xiang Song, MD    13803436909    songxiangeryuan@163.com   
Principal Investigator: Xiang Song, MD         
China, Sichuan
The Department of Lung oncology,Tumor Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ping Yu, MD    13881864070    yuping862@126.com   
Principal Investigator: Ping Yu, MD         
The Department of Oncology,People's Hospital Recruiting
Chengdu, Sichuan, China, 610072
Contact: Haitao Lan, MD    18981838376    lanht@sina.com   
Principal Investigator: Haitao Lan, MD         
China, Xinjiang
The Department of Oncology,First Affiliated Hospital of Medical University Recruiting
Urumqi, Xinjiang, China, 830054
Contact: Yiming Reheman, MD    15909002857    42113739@qq.com   
Principal Investigator: Yiming Reheman, MD         
The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University Recruiting
Urumqi, Xinjiang, China, 830054
Contact: Kegang Jiao, MD    13999828305    kateone@sohu.com   
Principal Investigator: Kegang Jiao, MD         
Sponsors and Collaborators
Shengqing Li
More Information

Responsible Party: Shengqing Li, Consultant, Associate professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01980849     History of Changes
Other Study ID Numbers: LCAN-20131105
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Shengqing Li, Fourth Military Medical University:
Nadroparin
venous thromboembolism prophylaxis

Additional relevant MeSH terms:
Lung Neoplasms
Thromboembolism
Venous Thromboembolism
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nadroparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action