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

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ClinicalTrials.gov Identifier: NCT03090880
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Ministry of Health, France
National Cancer Institute, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Lung Neoplasm Drug: Tinzaparin Sodium Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Symptomatic VTE events [ Time Frame: 6 months ]
    Objectively confirmed symptomatic VTE and death due to PE

  2. Venous thromboembolic events [ Time Frame: 12 months ]
    Objectively confirmed symptomatic or incidental VTE during the 12-months study period

  3. Major bleedings [ Time Frame: 6 months ]
    Major bleeding according to the ISTH criteria

  4. Death [ Time Frame: 6 months ]
    Overall mortality and causes of death

  5. Death [ Time Frame: 12 months ]
    Overall mortality and causes of death


Other Outcome Measures:
  1. Risk factors for venous thromboembolism [ Time Frame: 12 months ]
    Risk factors for venous thromboembolism



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090880


Contacts
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Contact: Guy Meyer, MD +33 156 093 461 guy.meyer@aphp.fr

Locations
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France
Hôpital Pontchaillou Terminated
Rennes, Bretagne, France, 35033
Centre Hospitalier régional d'Orléans Recruiting
Orléans, Centre, France, 45000
Centre Oscar Lambret Recruiting
Lille, Hauts De France, France, 59020
Hôpital Avicenne, Hôpitaux universitaires Paris Seine- Recruiting
Bobigny, Ile De France, France, 93000
Hôpital d'Instruction des Armées Percy Recruiting
Clamart, Ile De France, France, 92140
Hôpital Louis Mourier Recruiting
Colombes, Ile De France, France, 92700
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, Ile De France, France, 94000
Centre Hospitalier de Versailles André Mignot Recruiting
Le Chesnay, Ile De France, France, 78157
Hôpital Bicêtre Recruiting
Le Kremlin Bicêtre, Ile De France, France, 94275
Institut Curie Not yet recruiting
Paris, Ile De France, France, 75005
Hôpital Pitié Salpétrière Not yet recruiting
Paris, Ile De France, France, 75013
Centre Hospitalier Paris Saint-Joseph Recruiting
Paris, Ile De France, France, 75014
Institut Mutualiste Montsouris Terminated
Paris, Ile De France, France, 75014
Hôpital Européen Georges Pompidou Recruiting
Paris, Ile De France, France, 75015
Hôpital Bichat Claude Bernard Recruiting
Paris, Ile De France, France, 75018
Hôpital Tenon Recruiting
Paris, Ile De France, France, 75020
Centre cardiologique du Nord Recruiting
Saint Denis, Ile De France, France, 93200
Hôpital Foch Recruiting
Suresnes, Ile De France, France, 92150
Gustave Roussy Recruiting
Villejuif, Ile De France, France, 94805
Hôpital Larrey Recruiting
Toulouse, Languedoc-Roussillon-Midi-Pyrénées, France, 31059
CHU de Caen Recruiting
Caen, Normandie, France, 14033
CHU Poitiers Recruiting
Poitiers, Nouvelle-Aquitaine, France, 86000
Institut de cancérologie de l'Ouest Recruiting
Saint Herblain, Pays De La Loire, France, 44805
Centre Hospitalier Annecy Genevois Recruiting
Annecy, Rhône Alpes, France, 74374
Groupement Hospitalier Est Hospices civils de Lyon Terminated
Lyon, Rhônes Alpes, France, 69000
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint Priest, Rhônes-Alpes, France, 42270
CHU de Rouen, Hôpital Charles Nicolle Recruiting
Rouen, Seine Maritime, France, 76000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
National Cancer Institute, France
Investigators
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Principal Investigator: Guy Meyer, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03090880     History of Changes
Other Study ID Numbers: P150963
2016-002546-23 ( EudraCT Number )
PHRC ( Other Grant/Funding Number: 15-059 )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Low-molecular-weight Heparin
Tinzaparin
Additional relevant MeSH terms:
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Lung Neoplasms
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action