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Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (LCAN)

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nadroparin, long term
Nadroparin: short-term
Sponsored by
Shengqing Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring Nadroparin, venous thromboembolism prophylaxis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Department of Oncology，Southwest HospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine,Southwest HospitalRecruiting
  • The Department of Oncology，Ohtsubo HospitalRecruiting
  • The Department of Oncology，Fuling Central HospitalRecruiting
  • The Department of Oncology，Central HospitalRecruiting
  • The Department of Oncology，People's HospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine,Cancer HospitalRecruiting
  • The Department of Oncology，Henan University Affiliated Yihe HospitalRecruiting
  • The Department of Oncology，Cancer HospitalRecruiting
  • The Department of Oncology，Northern HospitalRecruiting
  • The Department of Oncology，Inner Mongolia Autonomous Region HospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine,Central HospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine,Second People's HospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong UniversityRecruiting
  • The Department of Pulmonary and Critical Care Medicine, Tangdu HospitalRecruiting
  • The Department of Pulmonary and Critical Care Medicine, Xijing HospitalRecruiting
  • The Department of Oncology，First Affiliated Hospital of Jiaotong UniversityRecruiting
  • The Department of Oncology，Yan'an University HospitalRecruiting
  • The Department of Oncology，Second Hospital of Shanxi Medical UniversityRecruiting
  • The Department of Lung oncology，Tumor HospitalRecruiting
  • The Department of Oncology，People's HospitalRecruiting
  • The Department of Oncology，First Affiliated Hospital of Medical UniversityRecruiting
  • The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long term prophylaxis

Short-term prophylaxis

Arm Description

Nadroparin, 0.4mL, subcutaneously, qid, given by long-term

Nadroparin, 0.4mL, subcutaneously, qid, given during hospitalization

Outcomes

Primary Outcome Measures

Incidence of venous thromboembolism

Secondary Outcome Measures

Incidence of bleeding

Full Information

First Posted
November 5, 2013
Last Updated
November 20, 2013
Sponsor
Shengqing Li
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1. Study Identification

Unique Protocol Identification Number
NCT01980849
Brief Title
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer
Acronym
LCAN
Official Title
Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shengqing Li

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Nadroparin, venous thromboembolism prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long term prophylaxis
Arm Type
Experimental
Arm Description
Nadroparin, 0.4mL, subcutaneously, qid, given by long-term
Arm Title
Short-term prophylaxis
Arm Type
Active Comparator
Arm Description
Nadroparin, 0.4mL, subcutaneously, qid, given during hospitalization
Intervention Type
Drug
Intervention Name(s)
Nadroparin, long term
Intervention Type
Drug
Intervention Name(s)
Nadroparin: short-term
Primary Outcome Measure Information:
Title
Incidence of venous thromboembolism
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of bleeding
Time Frame
During 6 months
Other Pre-specified Outcome Measures:
Title
Overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengqing Li, MD, PhD
Phone
+86-29-84771132
Facility Information:
Facility Name
The Department of Oncology，Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Ruan, MD
Phone
13883933815
Email
rzh1234@163.com
First Name & Middle Initial & Last Name & Degree
Zhihua Ruan, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine,Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Xiong, MD
Phone
13512345225
Email
xiongwei64@126.com
First Name & Middle Initial & Last Name & Degree
Wei Xiong, MD
Facility Name
The Department of Oncology，Ohtsubo Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueqin Yang, MD
Phone
15923366936
Email
yxq92@163.com
First Name & Middle Initial & Last Name & Degree
Xueqin Yang, MD
Facility Name
The Department of Oncology，Fuling Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
408000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Zhou, MD
Phone
18996706515
Email
qizhou112@163.com
First Name & Middle Initial & Last Name & Degree
Qi Zhou, MD
Facility Name
The Department of Oncology，Central Hospital
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guifang Zhang, MD
Phone
15637359110
Email
xxchzhangguifang@126.com
First Name & Middle Initial & Last Name & Degree
Guifang Zhang, MD
Facility Name
The Department of Oncology，People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifen Luo, MD
Phone
13783526222
Email
luozhifen123@126.com
First Name & Middle Initial & Last Name & Degree
Zhifen Luo, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine,Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqiu Zhao, MD
Phone
13938252350
Email
13938252350@163.com
First Name & Middle Initial & Last Name & Degree
Yanqiu Zhao, MD
Facility Name
The Department of Oncology，Henan University Affiliated Yihe Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450047
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanwei Guo, MD
Phone
15238608788
Email
zzymyygyw@163.com
First Name & Middle Initial & Last Name & Degree
Yanwei Guo, MD
Facility Name
The Department of Oncology，Cancer Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, MD
Phone
13847293318
Email
2469931063@qq.com
First Name & Middle Initial & Last Name & Degree
Jie Li, MD
Facility Name
The Department of Oncology，Northern Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
150200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengyun Wang, MD
Phone
15047243095
Email
wfy2826@163.com
First Name & Middle Initial & Last Name & Degree
Fengyun Wang, MD
Facility Name
The Department of Oncology，Inner Mongolia Autonomous Region Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010017
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuiying Zhang, MD
Phone
13947119586
Email
cenyao_2006@126.com
First Name & Middle Initial & Last Name & Degree
Cuiying Zhang, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Yin, MD
Phone
13014292909
Email
dmeiyin@163.com
First Name & Middle Initial & Last Name & Degree
Mei Yin, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine,Central Hospital
City
Baoji
State/Province
Shaanxi
ZIP/Postal Code
721008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengxia Wu, MD
Phone
13891731289
Email
Wzx1289@163.com
First Name & Middle Initial & Last Name & Degree
Zhengxia Wu, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine,Second People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhangqin Chen, MD
Phone
18991211556
Email
1191846052@qq.com
First Name & Middle Initial & Last Name & Degree
Zhangqin Chen, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manxiang Li, MD, PhD
Phone
15129312682
Email
Manxiangli@hotmail.com
First Name & Middle Initial & Last Name & Degree
Manxiang Li, MD, PhD
Facility Name
The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghong Xie, MD, PhD
Phone
+86-29-84777725
Email
xieyh65@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yonghong Xie, MD, PhD
Facility Name
The Department of Pulmonary and Critical Care Medicine, Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemin Yang, MD
Phone
+86-29-84775237
Email
yangxuemin0622@163.com
First Name & Middle Initial & Last Name & Degree
Xuemin Yang, MD
Facility Name
The Department of Oncology，First Affiliated Hospital of Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Yao, MD
Phone
13572101611
Email
13572101611@163.com
First Name & Middle Initial & Last Name & Degree
Yu Yao, MD
Facility Name
The Department of Oncology，Yan'an University Hospital
City
Yan'an
State/Province
Shaanxi
ZIP/Postal Code
716000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhao, MD
Phone
18809111001
Email
YDFYzhaohon@163.com
First Name & Middle Initial & Last Name & Degree
Hong Zhao, MD
Facility Name
The Department of Oncology，Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Song, MD
Phone
13803436909
Email
songxiangeryuan@163.com
First Name & Middle Initial & Last Name & Degree
Xiang Song, MD
Facility Name
The Department of Lung oncology，Tumor Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Yu, MD
Phone
13881864070
Email
yuping862@126.com
First Name & Middle Initial & Last Name & Degree
Ping Yu, MD
Facility Name
The Department of Oncology，People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Lan, MD
Phone
18981838376
Email
lanht@sina.com
First Name & Middle Initial & Last Name & Degree
Haitao Lan, MD
Facility Name
The Department of Oncology，First Affiliated Hospital of Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiming Reheman, MD
Phone
15909002857
Email
42113739@qq.com
First Name & Middle Initial & Last Name & Degree
Yiming Reheman, MD
Facility Name
The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kegang Jiao, MD
Phone
13999828305
Email
kateone@sohu.com
First Name & Middle Initial & Last Name & Degree
Kegang Jiao, MD

12. IPD Sharing Statement

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Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

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