Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (LCAN)

November 20, 2013 updated by: Shengqing Li

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • The Department of Oncology，Southwest Hospital
        • Contact:
        • Principal Investigator:
          • Zhihua Ruan, MD
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine,Southwest Hospital
        • Contact:
        • Principal Investigator:
          • Wei Xiong, MD
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • The Department of Oncology，Ohtsubo Hospital
        • Contact:
        • Principal Investigator:
          • Xueqin Yang, MD
      • Chongqing, Chongqing, China, 408000
        • Recruiting
        • The Department of Oncology，Fuling Central Hospital
        • Contact:
        • Principal Investigator:
          • Qi Zhou, MD
    • Henan
      • Xinxiang, Henan, China, 453000
        • Recruiting
        • The Department of Oncology，Central Hospital
        • Contact:
        • Principal Investigator:
          • Guifang Zhang, MD
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • The Department of Oncology，People's Hospital
        • Contact:
        • Principal Investigator:
          • zhifen luo, MD
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine,Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yanqiu Zhao, MD
      • Zhengzhou, Henan, China, 450047
        • Recruiting
        • The Department of Oncology，Henan University Affiliated Yihe Hospital
        • Contact:
        • Principal Investigator:
          • Yanwei Guo, MD
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014030
        • Recruiting
        • The Department of Oncology，Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jie Li, MD
      • Baotou, Inner Mongolia, China, 150200
        • Recruiting
        • The Department of Oncology，Northern Hospital
        • Contact:
        • Principal Investigator:
          • Fengyun Wang, MD
      • Hohhot, Inner Mongolia, China, 010017
        • Recruiting
        • The Department of Oncology，Inner Mongolia Autonomous Region Hospital
        • Contact:
        • Principal Investigator:
          • Cuiying Zhang, MD
    • Ningxia
      • Yinchuan, Ningxia, China, 750002
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital
        • Contact:
        • Principal Investigator:
          • Mei Yin, MD
    • Shaanxi
      • Baoji, Shaanxi, China, 721008
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine,Central Hospital
        • Contact:
        • Principal Investigator:
          • Zhengxia Wu, MD
      • Xi'an, Shaanxi, China, 710005
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine,Second People's Hospital
        • Contact:
        • Principal Investigator:
          • Zhangqin Chen, MD
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University
        • Contact:
        • Principal Investigator:
          • Manxiang Li, MD, PhD
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The department of pulmonary and critical care medicine, Tangdu hospital
        • Contact:
        • Principal Investigator:
          • Yonghong Xie, MD, PhD
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The department of pulmonary and critical care medicine, Xijing hospital
        • Contact:
        • Sub-Investigator:
          • Xuemin Yang, MD
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The Department of Oncology，First Affiliated Hospital of Jiaotong University
        • Contact:
        • Principal Investigator:
          • Yu Yao, MD
      • Yan'an, Shaanxi, China, 716000
        • Recruiting
        • The Department of Oncology，Yan'an University Hospital
        • Contact:
        • Principal Investigator:
          • Hong Zhao, MD
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • The Department of Oncology，Second Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Xiang Song, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • The Department of Lung oncology，Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Ping Yu, MD
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • The Department of Oncology，People's Hospital
        • Contact:
        • Principal Investigator:
          • Haitao Lan, MD
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • Recruiting
        • The Department of Oncology，First Affiliated Hospital of Medical University
        • Contact:
        • Principal Investigator:
          • Yiming Reheman, MD
      • Urumqi, Xinjiang, China, 830054
        • Recruiting
        • The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University
        • Contact:
        • Principal Investigator:
          • Kegang Jiao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long term prophylaxis
Nadroparin, 0.4mL, subcutaneously, qid, given by long-term
Drug: Nadroparin, long term
Active Comparator: Short-term prophylaxis
Nadroparin, 0.4mL, subcutaneously, qid, given during hospitalization
Drug: Nadroparin: short-term

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of venous thromboembolism
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of bleeding
Time Frame: During 6 months
During 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengqing Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCAN-20131105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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