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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shengqing Li, MD, PhD
  • Phone Number: +86-29-84771132

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of venous thromboembolism
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of bleeding
Time Frame: During 6 months
During 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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