Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

NCT03090880 | Terminated Phase 3 DMC

• 3 other identifiers: P1509632016-002546-23PHRC
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 27

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.

Conditions

Venous Thromboembolism; Lung Neoplasm

Keywords

Low-molecular-weight Heparin; Tinzaparin

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Symptomatic VTE events

  6 months

• Venous thromboembolic events

  12 months

• Major bleedings

  6 months

• Death

  6 months

• Death

  12 months

Other Outcomes (1)

• Risk factors for venous thromboembolism

  12 months

Study Arms (2)

Control

NO INTERVENTION

usual care,

Experimental

EXPERIMENTAL

tinzaparin sodium

Drug: Tinzaparin Sodium

Interventions

Tinzaparin Sodium DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG (Eastern Cooperative Oncology Group) score 0-2
• Life expectancy \>3 months

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• National Cancer Institute, France: collaborator

Study Sites (27)

Centre Hospitalier Annecy Genevois

Annecy, Auvergne-Rhône-Alpes, 74374, France

Location

Hôpital Pontchaillou

Rennes, Brittany Region, 35033, France

Location

Centre Hospitalier régional d'Orléans

Orléans, Centre-Val de Loire, 45000, France

Location

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

Location

CHU de Caen

Caen, Normandy, 14033, France

Location

CHU Poitiers

Poitiers, Nouvelle-Aquitaine, 86000, France

Location

Hôpital Larrey

Toulouse, Occitanie, 31059, France

Location

Institut de cancérologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, 44805, France

Location

Groupement Hospitalier Est Hospices civils de Lyon

Lyon, Rhônes Alpes, 69000, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest, Rhônes-Alpes, 42270, France

Location

CHU de Rouen, Hôpital Charles Nicolle

Rouen, Seine Maritime, 76000, France

Location

Hôpital Avicenne, Hôpitaux universitaires Paris Seine-

Bobigny, Île-de-France Region, 93000, France

Location

Hôpital d'Instruction des Armées Percy

Clamart, Île-de-France Region, 92140, France

Location

Hôpital Louis Mourier

Colombes, Île-de-France Region, 92700, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region, 94000, France

Location

Centre Hospitalier de Versailles André Mignot

Le Chesnay, Île-de-France Region, 78157, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94275, France

Location

Institut Curie

Paris, Île-de-France Region, 75005, France

Location

Hôpital Pitié Salpétrière

Paris, Île-de-France Region, 75013, France

Location

Centre Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Institut Mutualiste Montsouris

Paris, Île-de-France Region, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

Location

Hôpital Bichat Claude Bernard

Paris, Île-de-France Region, 75018, France

Location

Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

Centre cardiologique du Nord

Saint-Denis, Île-de-France Region, 93200, France

Location

Hôpital Foch

Suresnes, Île-de-France Region, 92150, France

Location

Gustave Roussy

Villejuif, Île-de-France Region, 94805, France

Location

MeSH Terms

Conditions

Venous Thromboembolism; Lung Neoplasms

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Guy Meyer, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: September 14, 2018
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: November 17, 2022

Record last verified: 2021-12

Locations

FR (27)