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Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT03090880
Collaborator
Ministry of Health, France (Other), National Cancer Institute, France (Other)
800
Enrollment
27
Locations
2
Arms
27.4
Anticipated Duration (Months)
29.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 20, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. venous thromboembolic events [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 [6 months]

    Objectively confirmed symptomatic VTE and death due to PE

  2. Venous thromboembolic events [12 months]

    Objectively confirmed symptomatic or incidental VTE during the 12-months study period

  3. Major bleedings [6 months]

    Major bleeding according to the ISTH criteria

  4. Death [6 months]

    Overall mortality and causes of death

  5. Death [12 months]

    Overall mortality and causes of death

Other Outcome Measures

  1. Risk factors for venous thromboembolism [12 months]

    Risk factors for venous thromboembolism

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Pontchaillou Rennes Bretagne France 35033
2 Centre Hospitalier régional d'Orléans Orléans Centre France 45000
3 Centre Oscar Lambret Lille Hauts De France France 59020
4 Hôpital Avicenne, Hôpitaux universitaires Paris Seine- Bobigny Ile De France France 93000
5 Hôpital d'Instruction des Armées Percy Clamart Ile De France France 92140
6 Hôpital Louis Mourier Colombes Ile De France France 92700
7 Centre Hospitalier Intercommunal de Créteil Créteil Ile De France France 94000
8 Centre Hospitalier de Versailles André Mignot Le Chesnay Ile De France France 78157
9 Hôpital Bicêtre Le Kremlin Bicêtre Ile De France France 94275
10 Institut Curie Paris Ile De France France 75005
11 Hôpital Pitié Salpétrière Paris Ile De France France 75013
12 Centre Hospitalier Paris Saint-Joseph Paris Ile De France France 75014
13 Institut Mutualiste Montsouris Paris Ile De France France 75014
14 Hôpital Européen Georges Pompidou Paris Ile De France France 75015
15 Hôpital Bichat Claude Bernard Paris Ile De France France 75018
16 Hôpital Tenon Paris Ile De France France 75020
17 Centre cardiologique du Nord Saint Denis Ile De France France 93200
18 Hôpital Foch Suresnes Ile De France France 92150
19 Gustave Roussy Villejuif Ile De France France 94805
20 Hôpital Larrey Toulouse Languedoc-Roussillon-Midi-Pyrénées France 31059
21 CHU de Caen Caen Normandie France 14033
22 CHU Poitiers Poitiers Nouvelle-Aquitaine France 86000
23 Institut de cancérologie de l'Ouest Saint Herblain Pays De La Loire France 44805
24 Centre Hospitalier Annecy Genevois Annecy Rhône Alpes France 74374
25 Groupement Hospitalier Est Hospices civils de Lyon Lyon Rhônes Alpes France 69000
26 Institut de Cancérologie Lucien Neuwirth Saint Priest Rhônes-Alpes France 42270
27 CHU de Rouen, Hôpital Charles Nicolle Rouen Seine Maritime France 76000

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03090880
Other Study ID Numbers:
  • P150963
  • 2016-002546-23
  • PHRC
First Posted:
Mar 27, 2017
Last Update Posted:
Oct 1, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
Lung Neoplasms
Thromboembolism
Venous Thromboembolism
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin

Study Results

No Results Posted as of Oct 1, 2019