Prophylaxis of Venous Thromboembolism in Advanced Lung Ca... | NCT03090880

ID	Type	Description	Link
2016-002546-23	EudraCT Number
PHRC	Other Grant/Funding Number	15-059

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives.

The sponsor has decided to prematurely stop inclusions on January 13, 2022.

Expanded Access Info

Start Date

Sep 14, 2018Actual

Primary Completion Date

Aug 18, 2021Actual

Completion Date

Aug 18, 2021Actual

First Submitted Date

Mar 21, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 27, 2017Actual

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 14, 2022

Last Update Posted Date

Nov 17, 2022Actual

Name	Class
Ministry of Health, France	OTHER_GOV
National Cancer Institute, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.

Detailed Description

Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.

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

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	usual care,
Experimental	Experimental	tinzaparin sodium	Drug: Tinzaparin Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tinzaparin Sodium	Drug	Subcutaneous tinzaparin 4,500 IU once daily for six months.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
venous thromboembolic events	All venous thromboembolism (VTE) events during the six-month treatment period including: objectively confirmed symptomatic pulmonary embolism (PE), objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis), objectively confirmed symptomatic upper extremity DVT, objectively confirmed incidentally diagnosed PE or proximal DVT death due to PE.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Symptomatic VTE events	Objectively confirmed symptomatic VTE and death due to PE	6 months
Venous thromboembolic events	Objectively confirmed symptomatic or incidental VTE during the 12-months study period

Other Outcomes

Measure	Description	Time Frame
Risk factors for venous thromboembolism	Risk factors for venous thromboembolism	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Social security affiliation
Written informed consent
Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission
D-dimer > 1,500 µg/L
First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion
ECOG (Eastern Cooperative Oncology Group) score 0-2
Life expectancy >3 months

Exclusion Criteria:

Hypersensitivity to heparin or to any excipients
Septic endocarditis
History of heparin-induced thrombocytopenia
Ongoing anticoagulant treatment at therapeutic dosage
VTE at inclusion
Creatinin clearance <30 mL/min
Active bleeding
Platelet count < 100 G/L at inclusion
Severe hepatic insufficiency
Cancer treated exclusively with supportive care
Aspirin at daily dosage > 160 mg
Pregnancy
Patient under tutorship or curatorship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guy Meyer, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Annecy Genevois		Annecy	Auvergne-Rhône-Alpes	74374	France
Hôpital Pontchaillou

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates