Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer
LCAN
Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin
1 other identifier
interventional
272
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 lung-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedNovember 21, 2013
November 1, 2013
3 years
November 5, 2013
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of venous thromboembolism
12 weeks
Secondary Outcomes (1)
Incidence of bleeding
During 6 months
Other Outcomes (1)
Overall survival
2 years
Study Arms (2)
Long term prophylaxis
EXPERIMENTALNadroparin, 0.4mL, subcutaneously, qid, given by long-term
Short-term prophylaxis
ACTIVE COMPARATORNadroparin, 0.4mL, subcutaneously, qid, given during hospitalization
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Examination revealed any part of venous thromboembolism
- Chemotherapy regimens containing bevacizumab or Endostar
- Severe coagulopathy
- Active bleeding within two weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shengqing Lilead
Study Sites (24)
The Department of Oncology,Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
The Department of Pulmonary and Critical Care Medicine,Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
The Department of Oncology,Ohtsubo Hospital
Chongqing, Chongqing Municipality, 400042, China
The Department of Oncology,Fuling Central Hospital
Chongqing, Chongqing Municipality, 408000, China
The Department of Oncology,Central Hospital
Xinxiang, Henan, 453000, China
The Department of Oncology,People's Hospital
Zhengzhou, Henan, 450003, China
The Department of Pulmonary and Critical Care Medicine,Cancer Hospital
Zhengzhou, Henan, 450008, China
The Department of Oncology,Henan University Affiliated Yihe Hospital
Zhengzhou, Henan, 450047, China
The Department of Oncology,Cancer Hospital
Baotou, Inner Mongolia, 014030, China
The Department of Oncology,Northern Hospital
Baotou, Inner Mongolia, 150200, China
The Department of Oncology,Inner Mongolia Autonomous Region Hospital
Hohhot, Inner Mongolia, 010017, China
The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital
Yinchuan, Ningxia, 750002, China
The Department of Pulmonary and Critical Care Medicine,Central Hospital
Baoji, Shaanxi, 721008, China
The Department of Pulmonary and Critical Care Medicine,Second People's Hospital
Xi'an, Shaanxi, 710005, China
The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University
Xi'an, Shaanxi, 710032, China
The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital
Xi'an, Shaanxi, 710032, China
The Department of Pulmonary and Critical Care Medicine, Xijing Hospital
Xi'an, Shaanxi, 710032, China
The Department of Oncology,First Affiliated Hospital of Jiaotong University
Xi'an, Shaanxi, 710061, China
The Department of Oncology,Yan'an University Hospital
Yan’an, Shaanxi, 716000, China
The Department of Oncology,Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Department of Lung oncology,Tumor Hospital
Chengdu, Sichuan, 610041, China
The Department of Oncology,People's Hospital
Chengdu, Sichuan, 610072, China
The Department of Oncology,First Affiliated Hospital of Medical University
Ürümqi, Xinjiang, 830054, China
The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University
Ürümqi, Xinjiang, 830054, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant, Associate professor
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 11, 2013
Study Start
November 1, 2013
Primary Completion
November 1, 2016
Last Updated
November 21, 2013
Record last verified: 2013-11