Clinical trial NCT03090880: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
Official title: Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Venous Thromboembolism
Lung Neoplasm
Keywords: Low-molecular-weight Heparin
Tinzaparin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: National Cancer Institute, France
First posted: 2017-03-27
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: venous thromboembolic events
timeFrame: 6 months
Secondary outcomes:
measure: Symptomatic VTE events
timeFrame: 6 months
measure: Venous thromboembolic events
timeFrame: 12 months
measure: Major bleedings
timeFrame: 6 months
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 12 months
Other outcomes:
measure: Risk factors for venous thromboembolism
timeFrame: 12 months
Locations:
city: Rennes
country: France
facility: Hôpital Pontchaillou
state: Bretagne
city: Orléans
country: France
facility: Centre Hospitalier régional d'Orléans
state: Centre
city: Lille
country: France
facility: Centre Oscar Lambret
state: Hauts De France
city: Bobigny
country: France
facility: Hôpital Avicenne, Hôpitaux universitaires Paris Seine-
state: Ile De France
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
state: Ile De France
city: Colombes
country: France
facility: Hôpital Louis Mourier
state: Ile De France
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Ile De France
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot
state: Ile De France
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
state: Ile De France
city: Paris
country: France
facility: Institut Curie
state: Ile De France
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
state: Ile De France
city: Paris
country: France
facility: Centre Hospitalier Paris Saint-Joseph
state: Ile De France
city: Paris
country: France
facility: Institut Mutualiste Montsouris
state: Ile De France
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
state: Ile De France
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
state: Ile De France
city: Paris
country: France
facility: Hôpital Tenon
state: Ile De France
city: Saint Denis
country: France
facility: Centre cardiologique du Nord
state: Ile De France
city: Suresnes
country: France
facility: Hôpital Foch
state: Ile De France
city: Villejuif
country: France
facility: Gustave Roussy
state: Ile De France
city: Toulouse
country: France
facility: Hôpital Larrey
state: Languedoc-Roussillon-Midi-Pyrénées
city: Caen
country: France
facility: CHU de Caen
state: Normandie
city: Poitiers
country: France
facility: CHU Poitiers
state: Nouvelle-Aquitaine
city: Saint Herblain
country: France
facility: Institut de cancérologie de l'Ouest
state: Pays De La Loire
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
state: Rhône Alpes
city: Lyon
country: France
facility: Groupement Hospitalier Est Hospices civils de Lyon
state: Rhônes Alpes
city: Saint Priest
country: France
facility: Institut de Cancérologie Lucien Neuwirth
state: Rhônes-Alpes
city: Rouen
country: France
facility: CHU de Rouen, Hôpital Charles Nicolle
state: Seine Maritime
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guy Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: