Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

Phase 3

• Conditions: Lung Cancer
• Interventions: Drug: Nadroparin, long term

• Registration Number: NCT01980849
• Lead Sponsor: Shengqing Li

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.

Study Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-11
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-21
• Primary Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long term prophylaxis	Nadroparin, long term	Nadroparin, 0.4mL, subcutaneously, qid, given by long-term

Primary Outcome Measures

Name	Time	Method
Incidence of venous thromboembolism	12 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of bleeding	During 6 months

Trial Locations

Locations (23)

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，Ohtsubo Hospital; 🇨🇳 Chongqing, Chongqing, China

The Department of Oncology，Fuling Central Hospital; 🇨🇳 Chongqing, Chongqing, China

The Department of Oncology，Central Hospital; 🇨🇳 Xinxiang, Henan, China

The Department of Oncology，People's Hospital; 🇨🇳 Chengdu, Sichuan, China

The Department of Pulmonary and Critical Care Medicine,Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

The Department of Oncology，Henan University Affiliated Yihe Hospital; 🇨🇳 Zhengzhou, Henan, China

The Department of Oncology，Cancer Hospital; 🇨🇳 Baotou, Inner Mongolia, China

The Department of Oncology，Northern Hospital; 🇨🇳 Baotou, Inner Mongolia, China

Scroll for more (13 remaining)