Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

Lung Cancer Clinical Trial

— LCAN  

Official title:

Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01980849
• Other study ID #: LCAN-20131105
• Status: Recruiting
• Phase: Phase 3
• First received: November 5, 2013
• Last updated: November 20, 2013
• Start date: November 2013

Study information

• Verified date: November 2013
• Source: Fourth Military Medical University
• Contact: Shengqing Li, MD, PhD
• Phone: +86-29-84771132
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stage ? B and ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Nadroparin, long term

• Nadroparin: short-term

Locations

Country	Name	City	State
China	The Department of Pulmonary and Critical Care Medicine,Central Hospital	Baoji	Shaanxi
China	The Department of Oncology,Cancer Hospital	Baotou	Inner Mongolia
China	The Department of Oncology,Northern Hospital	Baotou	Inner Mongolia
China	The Department of Lung oncology,Tumor Hospital	Chengdu	Sichuan
China	The Department of Oncology,People's Hospital	Chengdu	Sichuan
China	The Department of Oncology,Fuling Central Hospital	Chongqing	Chongqing
China	The Department of Oncology,Ohtsubo Hospital	Chongqing	Chongqing
China	The Department of Oncology,Southwest Hospital	Chongqing	Chongqing
China	The Department of Pulmonary and Critical Care Medicine,Southwest Hospital	Chongqing	Chongqing
China	The Department of Oncology,Inner Mongolia Autonomous Region Hospital	Hohhot	Inner Mongolia
China	The Department of Oncology,Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Department of Oncology,First Affiliated Hospital of Medical University	Urumqi	Xinjiang
China	The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University	Urumqi	Xinjiang
China	The Department of Oncology,First Affiliated Hospital of Jiaotong University	Xi'an	Shaanxi
China	The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University	Xi'an	Shaanxi
China	The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital	Xi'an	Shaanxi
China	The Department of Pulmonary and Critical Care Medicine, Xijing Hospital	Xi'an	Shaanxi
China	The Department of Pulmonary and Critical Care Medicine,Second People's Hospital	Xi'an	Shaanxi
China	The Department of Oncology,Central Hospital	Xinxiang	Henan
China	The Department of Oncology,Yan'an University Hospital	Yan'an	Shaanxi
China	The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital	Yinchuan	Ningxia
China	The Department of Oncology,Henan University Affiliated Yihe Hospital	Zhengzhou	Henan
China	The Department of Oncology,People's Hospital	Zhengzhou	Henan
China	The Department of Pulmonary and Critical Care Medicine,Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shengqing Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival		2 years	No
Primary	Incidence of venous thromboembolism		12 weeks	No
Secondary	Incidence of bleeding		During 6 months	Yes