Prophylaxis of Venous Thromboembolism in Advanced Lung Ca... | NCT01980849

Studies
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

NCT01980849

Sponsor

Shengqing Li

Status

Unknown status

Last Update Posted

Nov 21, 2013Estimated

Enrollment

272Estimated

Phase

Phase 3

Conditions

Lung Cancer

Interventions

Nadroparin, long term
Nadroparin: short-term

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2016Estimated

Completion Date

Not provided

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Nov 8, 2013

First Posted Date

Nov 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2013

Last Update Posted Date

Nov 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shengqing Li, Consultant, Associate professor, Air Force Military Medical University, ChinaSponsor-Investigator

Lead Sponsor

Shengqing LiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

272Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nadroparin, long term	Drug		Long term prophylaxis
Nadroparin: short-term

Measure	Description	Time Frame
Incidence of venous thromboembolism		12 weeks

Measure	Description	Time Frame
Incidence of bleeding		During 6 months

Measure	Description	Time Frame
Overall survival		2 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shengqing Li, MD, PhD	Contact	+86-29-84771132

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Department of Oncology，Southwest Hospital	Recruiting	Chongqing	Chongqing Municipality	400038	China

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017762	Nadroparin

Ancestor Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides

Browse Leaves

Not provided

Browse Branches

Not provided