Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-14

Study Completion Date

2021-08-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Thromboembolism Lung Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

usual care,

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

tinzaparin sodium

Group Type EXPERIMENTAL

Tinzaparin Sodium

Intervention Type DRUG

Subcutaneous tinzaparin 4,500 IU once daily for six months.

Interventions

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Tinzaparin Sodium

Subcutaneous tinzaparin 4,500 IU once daily for six months.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Centre Hospitalier Annecy Genevois

Annecy, Auvergne-Rhône-Alpes, France

Site Status

Hôpital Pontchaillou

Rennes, Brittany Region, France

Site Status

Centre Hospitalier régional d'Orléans

Orléans, Centre-Val de Loire, France

Site Status

Centre Oscar Lambret

Lille, Hauts-de-France, France

Site Status

CHU de Caen

Caen, Normandy, France

Site Status

CHU Poitiers

Poitiers, Nouvelle-Aquitaine, France

Site Status

Hôpital Larrey

Toulouse, Occitanie, France

Site Status

Institut de cancérologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, France

Site Status

Groupement Hospitalier Est Hospices civils de Lyon

Lyon, Rhônes Alpes, France

Site Status

Institut de Cancérologie Lucien Neuwirth

Saint-Priest, Rhônes-Alpes, France

Site Status

CHU de Rouen, Hôpital Charles Nicolle

Rouen, Seine Maritime, France

Site Status

Hôpital Avicenne, Hôpitaux universitaires Paris Seine-

Bobigny, Île-de-France Region, France

Site Status

Hôpital d'Instruction des Armées Percy

Clamart, Île-de-France Region, France

Site Status

Hôpital Louis Mourier

Colombes, Île-de-France Region, France

Site Status

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region, France

Site Status

Centre Hospitalier de Versailles André Mignot

Le Chesnay, Île-de-France Region, France

Site Status