Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE) (PROVE)

November 14, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35033
        • Hôpital Pontchaillou
    • Centre
      • Orléans, Centre, France, 45000
        • Centre Hospitalier Régional d'Orléans
    • Hauts De France
      • Lille, Hauts De France, France, 59020
        • Centre Oscar Lambret
    • Ile De France
      • Bobigny, Ile De France, France, 93000
        • Hôpital Avicenne, Hôpitaux universitaires Paris Seine-
      • Clamart, Ile De France, France, 92140
        • Hôpital d'Instruction des Armées PERCY
      • Colombes, Ile De France, France, 92700
        • Hopital Louis Mourier
      • Créteil, Ile De France, France, 94000
        • Centre Hospitalier Intercommunal de Créteil
      • Le Chesnay, Ile De France, France, 78157
        • Centre Hospitalier de Versailles André Mignot
      • Le Kremlin Bicêtre, Ile De France, France, 94275
        • Hopital Bicetre
      • Paris, Ile De France, France, 75005
        • Institut Curie
      • Paris, Ile De France, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, Ile De France, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, Ile De France, France, 75013
        • Hopital Pitie Salpetriere
      • Paris, Ile De France, France, 75014
        • Centre Hospitalier Paris Saint-Joseph
      • Paris, Ile De France, France, 75018
        • Hopital Bichat Claude Bernard
      • Paris, Ile De France, France, 75020
        • Hopital Tenon
      • Saint Denis, Ile De France, France, 93200
        • Centre Cardiologique du Nord
      • Suresnes, Ile De France, France, 92150
        • Hopital Foch
      • Villejuif, Ile De France, France, 94805
        • Gustave Roussy
    • Languedoc-Roussillon-Midi-Pyrénées
      • Toulouse, Languedoc-Roussillon-Midi-Pyrénées, France, 31059
        • Hôpital Larrey
    • Normandie
      • Caen, Normandie, France, 14033
        • CHU de Caen
    • Nouvelle-Aquitaine
      • Poitiers, Nouvelle-Aquitaine, France, 86000
        • CHU Poitiers
    • Pays De La Loire
      • Saint Herblain, Pays De La Loire, France, 44805
        • Institut de Cancerologie de l'Ouest
    • Rhône Alpes
      • Annecy, Rhône Alpes, France, 74374
        • Centre Hospitalier Annecy Genevois
    • Rhônes Alpes
      • Lyon, Rhônes Alpes, France, 69000
        • Groupement Hospitalier Est Hospices civils de Lyon
    • Rhônes-Alpes
      • Saint Priest, Rhônes-Alpes, France, 42270
        • Institut de Cancérologie Lucien Neuwirth
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76000
        • CHU de Rouen, Hopital Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
usual care,
Experimental: Experimental
tinzaparin sodium
Drug: Tinzaparin Sodium
Subcutaneous tinzaparin 4,500 IU once daily for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
venous thromboembolic events
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic VTE events
Time Frame: 6 months
Objectively confirmed symptomatic VTE and death due to PE
6 months
Venous thromboembolic events
Time Frame: 12 months
Objectively confirmed symptomatic or incidental VTE during the 12-months study period
12 months
Major bleedings
Time Frame: 6 months
Major bleeding according to the ISTH criteria
6 months
Death
Time Frame: 6 months
Overall mortality and causes of death
6 months
Death
Time Frame: 12 months
Overall mortality and causes of death
12 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France
National Cancer Institute, France

Investigators

  • Principal Investigator: Guy Meyer, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2018

Primary Completion (Actual)

August 18, 2021

Study Completion (Actual)

August 18, 2021

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P150963
  • PHRC (2001/1939)
  • 2016-002546-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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