Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

NCT ID: NCT01980849

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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Nadroparin venous thromboembolism prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Long term prophylaxis

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

Group Type EXPERIMENTAL

Nadroparin, long term

Intervention Type DRUG

Short-term prophylaxis

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

Group Type ACTIVE_COMPARATOR

Nadroparin: short-term

Intervention Type DRUG

Interventions

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Nadroparin, long term

Intervention Type DRUG

Nadroparin: short-term

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengqing Li

OTHER

Sponsor Role lead

Responsible Party

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Shengqing Li

Consultant, Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Department of Oncology,Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine,Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The Department of Oncology,Ohtsubo Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The Department of Oncology,Fuling Central Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The Department of Oncology,Central Hospital

Xinxiang, Henan, China

Site Status RECRUITING

The Department of Oncology,People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine,Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The Department of Oncology,Henan University Affiliated Yihe Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The Department of Oncology,Cancer Hospital

Baotou, Inner Mongolia, China

Site Status RECRUITING

The Department of Oncology,Northern Hospital

Baotou, Inner Mongolia, China

Site Status RECRUITING

The Department of Oncology,Inner Mongolia Autonomous Region Hospital

Hohhot, Inner Mongolia, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital

Yinchuan, Ningxia, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine,Central Hospital

Baoji, Shaanxi, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine,Second People's Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine, Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

The Department of Oncology,First Affiliated Hospital of Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

The Department of Oncology,Yan'an University Hospital

Yan’an, Shaanxi, China

Site Status RECRUITING

The Department of Oncology,Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

The Department of Lung oncology,Tumor Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

The Department of Oncology,People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

The Department of Oncology,First Affiliated Hospital of Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengqing Li, MD, PhD

Role: CONTACT

Phone: +86-29-84771132

Facility Contacts

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Zhihua Ruan, MD

Role: primary

Wei Xiong, MD

Role: primary

Xueqin Yang, MD

Role: primary

Qi Zhou, MD

Role: primary

Guifang Zhang, MD

Role: primary

Zhifen Luo, MD

Role: primary

Yanqiu Zhao, MD

Role: primary

Yanwei Guo, MD

Role: primary

Jie Li, MD

Role: primary

Fengyun Wang, MD

Role: primary

Cuiying Zhang, MD

Role: primary

Mei Yin, MD

Role: primary

Zhengxia Wu, MD

Role: primary

Zhangqin Chen, MD

Role: primary

Manxiang Li, MD, PhD

Role: primary

Yonghong Xie, MD, PhD

Role: primary

Xuemin Yang, MD

Role: primary

Yu Yao, MD

Role: primary

Hong Zhao, MD

Role: primary

Xiang Song, MD

Role: primary

Ping Yu, MD

Role: primary

Haitao Lan, MD

Role: primary

Yiming Reheman, MD

Role: primary

Kegang Jiao, MD

Role: primary

Other Identifiers

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LCAN-20131105

Identifier Type: -

Identifier Source: org_study_id