Clinical trial NCT01980849: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer
Official title: Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: Nadroparin
venous thromboembolism prophylaxis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of venous thromboembolism
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of bleeding
timeFrame: During 6 months
Other outcomes:
measure: Overall survival
timeFrame: 2 years
Locations:
city: Chongqing
country: China
facility: The Department of Oncology，Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Department of Pulmonary and Critical Care Medicine,Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Department of Oncology，Ohtsubo Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Department of Oncology，Fuling Central Hospital
state: Chongqing
city: Xinxiang
country: China
facility: The Department of Oncology，Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Department of Oncology，People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Department of Pulmonary and Critical Care Medicine,Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Department of Oncology，Henan University Affiliated Yihe Hospital
state: Henan
city: Baotou
country: China
facility: The Department of Oncology，Cancer Hospital
state: Inner Mongolia
city: Baotou
country: China
facility: The Department of Oncology，Northern Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Department of Oncology，Inner Mongolia Autonomous Region Hospital
state: Inner Mongolia
city: Yinchuan
country: China
facility: The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital
state: Ningxia
city: Baoji
country: China
facility: The Department of Pulmonary and Critical Care Medicine,Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The Department of Pulmonary and Critical Care Medicine,Second People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The Department of Pulmonary and Critical Care Medicine, Xijing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The Department of Oncology，First Affiliated Hospital of Jiaotong University
state: Shaanxi
city: Yan'an
country: China
facility: The Department of Oncology，Yan'an University Hospital
state: Shaanxi
city: Taiyuan
country: China
facility: The Department of Oncology，Second Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: The Department of Lung oncology，Tumor Hospital
state: Sichuan
city: Chengdu
country: China
facility: The Department of Oncology，People's Hospital
state: Sichuan
city: Urumqi
country: China
facility: The Department of Oncology，First Affiliated Hospital of Medical University
state: Xinjiang
city: Urumqi
country: China
facility: The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University
state: Xinjiang
Study officials:
References: