Venous ThromboembolismPhase 3PROVENCT03090880
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
A Phase 3 study testing Tinzaparin Sodium in people with Venous Thromboembolism and Lung Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 27 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Lung Neoplasm
- What is being tested?
- Tinzaparin Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 27 sitesFrance
- Study dates
- 14 Sep 2018to 18 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Centre Hospitalier Annecy Genevois
Annecy, Auvergne-Rhône-Alpes, 74374
Hôpital Avicenne, Hôpitaux universitaires Paris Seine-
Bobigny, Île-de-France Region, 93000
CHU de Caen
Caen, Normandy, 14033
Hôpital d'Instruction des Armées Percy
Clamart, Île-de-France Region, 92140
Hôpital Louis Mourier
Colombes, Île-de-France Region, 92700
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, 94000
Centre Hospitalier de Versailles André Mignot
Le Chesnay, Île-de-France Region, 78157
Hôpital Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94275
Centre Oscar Lambret
Lille, Hauts-de-France, 59020
Groupement Hospitalier Est Hospices civils de Lyon
Lyon, Rhônes Alpes, 69000
Centre Hospitalier régional d'Orléans
Orléans, Centre-Val de Loire, 45000
Institut Curie
Paris, Île-de-France Region, 75005
Hôpital Pitié Salpétrière
Paris, Île-de-France Region, 75013
Centre Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
Institut Mutualiste Montsouris
Paris, Île-de-France Region, 75014
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, 75015
Hôpital Bichat Claude Bernard
Paris, Île-de-France Region, 75018
Hôpital Tenon
Paris, Île-de-France Region, 75020
CHU Poitiers
Poitiers, New Aquitaine, 86000
Hôpital Pontchaillou
Rennes, Brittany Region, 35033
CHU de Rouen, Hôpital Charles Nicolle
Rouen, Seine Maritime, 76000
Centre cardiologique du Nord
Saint-Denis, Île-de-France Region, 93200
Institut de cancérologie de l'Ouest
Saint-Herblain, Pays de la Loire Region, 44805
Institut de Cancérologie Lucien Neuwirth
Saint-Priest, Rhônes-Alpes, 42270
Hôpital Foch
Suresnes, Île-de-France Region, 92150
Hôpital Larrey
Toulouse, Occitanie, 31059
Gustave Roussy
Villejuif, Île-de-France Region, 94805
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Thromboembolism, Lung Neoplasm
- Being tested
- Tinzaparin Sodium
- Keywords
- Low-molecular-weight Heparin, Tinzaparin
- Medical subject headings
- Venous Thromboembolism, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinzaparin SodiumDrug
Subcutaneous tinzaparin 4,500 IU once daily for six months.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | usual care, |
| Experimental | Experimental | tinzaparin sodium Receives: Drug: Tinzaparin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Symptomatic VTE events
Objectively confirmed symptomatic VTE and death due to PE
Measured: 6 months
Venous thromboembolic events
Objectively confirmed symptomatic or incidental VTE during the 12-months study period
Measured: 12 months
Major bleedings
Major bleeding according to the ISTH criteria
Measured: 6 months
Death
Overall mortality and causes of death
Measured: 6 months
Death
Overall mortality and causes of death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start14 Sep 2018
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Why it stopped: The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Guy Meyer, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090880
- Sponsor's protocol ID
- P150963
- Other IDs
- 2016-002546-23, PHRC, 2016
- Acronym
- PROVE
- Status last verified
- Dec 2021
- First submitted
- 21 Mar 2017
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
- ClinicalTrials.gov ID
- NCT03090880
- Acronym / sponsor ID
- PROVE / P150963
- Conditions
- Venous Thromboembolism, Lung Neoplasm
- Keywords
- Low-molecular-weight Heparin, Tinzaparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –usual care, |
| Experimental | Experimental | Drug: Tinzaparin Sodiumtinzaparin sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- Hypersensitivity to heparin or to any excipients
- Septic endocarditis
- History of heparin-induced thrombocytopenia
- Ongoing anticoagulant treatment at therapeutic dosage
- VTE at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinzaparin SodiumSubcutaneous tinzaparin 4,500 IU once daily for six months. | Drug | Experimental |
Primary outcome
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.
5 secondary outcomes
Symptomatic VTE events
Time frame: 6 months
Venous thromboembolic events
Time frame: 12 months
Major bleedings
Time frame: 6 months
Death
Time frame: 6 months
Death
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Meyer, MD principal investigator
Assistance Publique - Hôpitaux de Paris
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tinzaparin Sodium in people with Venous Thromboembolism and Lung Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
venous thromboembolic events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.