NCT01980849

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P25-P50 for phase_3 lung-cancer

Geographic Reach
1 country

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

November 5, 2013

Last Update Submit

November 20, 2013

Conditions

Keywords

Nadroparinvenous thromboembolism prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Incidence of venous thromboembolism

    12 weeks

Secondary Outcomes (1)

  • Incidence of bleeding

    During 6 months

Other Outcomes (1)

  • Overall survival

    2 years

Study Arms (2)

Long term prophylaxis

EXPERIMENTAL

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

Drug: Nadroparin, long term

Short-term prophylaxis

ACTIVE COMPARATOR

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

Drug: Nadroparin: short-term

Interventions

Long term prophylaxis
Short-term prophylaxis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Examination revealed any part of venous thromboembolism
  • Chemotherapy regimens containing bevacizumab or Endostar
  • Severe coagulopathy
  • Active bleeding within two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

The Department of Oncology,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

The Department of Pulmonary and Critical Care Medicine,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

The Department of Oncology,Ohtsubo Hospital

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

The Department of Oncology,Fuling Central Hospital

Chongqing, Chongqing Municipality, 408000, China

RECRUITING

The Department of Oncology,Central Hospital

Xinxiang, Henan, 453000, China

RECRUITING

The Department of Oncology,People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The Department of Pulmonary and Critical Care Medicine,Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

The Department of Oncology,Henan University Affiliated Yihe Hospital

Zhengzhou, Henan, 450047, China

RECRUITING

The Department of Oncology,Cancer Hospital

Baotou, Inner Mongolia, 014030, China

RECRUITING

The Department of Oncology,Northern Hospital

Baotou, Inner Mongolia, 150200, China

RECRUITING

The Department of Oncology,Inner Mongolia Autonomous Region Hospital

Hohhot, Inner Mongolia, 010017, China

RECRUITING

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

Yinchuan, Ningxia, 750002, China

RECRUITING

The Department of Pulmonary and Critical Care Medicine,Central Hospital

Baoji, Shaanxi, 721008, China

RECRUITING

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

Xi'an, Shaanxi, 710005, China

RECRUITING

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

Xi'an, Shaanxi, 710032, China

RECRUITING

The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

The Department of Pulmonary and Critical Care Medicine, Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

The Department of Oncology,First Affiliated Hospital of Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

The Department of Oncology,Yan'an University Hospital

Yan’an, Shaanxi, 716000, China

RECRUITING

The Department of Oncology,Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

The Department of Lung oncology,Tumor Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

The Department of Oncology,People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

The Department of Oncology,First Affiliated Hospital of Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

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

Ürümqi, Xinjiang, 830054, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nadroparin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Shengqing Li, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, Associate professor

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 11, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2016

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations