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Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (LCAN)

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ClinicalTrials.gov Identifier: NCT01980849
Recruitment Status : Unknown
Verified November 2013 by Shengqing Li, Air Force Military Medical University, China.
Recruitment status was:  Recruiting
First Posted : November 11, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Shengqing Li, Air Force Military Medical University, China

Study Description
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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
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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

Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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Contact: Shengqing Li, MD, PhD +86-29-84771132

Locations
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Sponsors and Collaborators
Shengqing Li
More Information
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Responsible Party: Shengqing Li, Consultant, Associate professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT01980849    
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, Air Force Military Medical University, China:
Nadroparin
venous thromboembolism prophylaxis
Additional relevant MeSH terms:
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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