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NeoplasmPhase 3CASTA-DIVANCT02746185

Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban

A Phase 3 study testing rivaroxaban and Low-molecular-weight heparin in people with Neoplasm and Venous Thromboembolism, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm, Venous Thromboembolism
What is being tested?
rivaroxaban and Low-molecular-weight heparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
15 sitesFrance
Study dates
Sep 2016to 25 Apr 2018
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
  • Solid active cancer, high grade lymphoma or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion.
  • Histologically or cytologically proven cancer.
  • Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally
  • High-risk of recurrent Venous thromboembolism (VTE) defined by a score of 0 or ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) non metastatic tumor (-2), previous VTE (+1).

Who cannot join

  • Exclusive adjuvant hormonal treatment with no measurable residual disease
  • Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT
  • Isolated distal deep vein thrombosis (DVT) of the legs
  • Isolated upper-extremity DVT or superior vena cava thrombosis
  • Isolated visceral thrombosis
  • Platelet count < 50 000 G/L
Show all 19Show fewer
  • Active bleeding
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
  • Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage
  • Vena cava filter at inclusion
  • Fibrinolytic therapy within 3 days preceding inclusion
  • Creatinine clearance < 30 ml/min according to Cockcroft-Gault formula
  • Previous heparin-induced thrombocytopenia
  • Anticoagulant treatment at curative dosage for more than 3 days before inclusion
  • Pregnancy or lack of effective contraceptive treatment for women of childbearing age
  • Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole
  • Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin.
  • Life expectancy < 3 months
  • Eastern Cooperative Oncology Group (ECOG) level 3 or 4

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHU Amiens - Medecine vasculaire (003)

    Amiens

  • CHU Angers - Medecin Interne (002)

    Angers

  • Espace Artois Santé

    Arras

  • Hopital Saint Andre - Medecine vasculaire (015)

    Bordeaux

  • CHU Brest - Departement de medecin interne et pneumologie (008)

    Brest

  • CHU Le Bocage - Medecine interne 1 (014)

    Dijon

  • CHU Grenoble - Medecine vasculaire (007)

    Grenoble

  • CH Départemental La Roche sur Yon

    La Roche-sur-Yon

  • Centre hospitalier Lyon Sud - Medecine interne (011)

    Lyon

  • CHRU de Nîmes - Pneumologie (012)

    Nîmes

  • HEGP - Pneumologie et soins intensifs (001)

    Paris, 75015

  • Institut Curie - Soins de support en Cancerologie (020)

    Paris

  • CHU Saint Etienne - Medecin vasculaire et therapeutique (006)

    Saint-Etienne

  • Hopital Saine Musse - Service de Medecine Vasculaire (010)

    Toulon

  • CHU Rangueil - Medecin Vasculaire (019)

    Toulouse

Other trials in France

About this study

Official title: Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.

The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.

Read the detailed description

Patients with active cancer and symptomatic pulmonary embolism, proximal deep vein thrombosis, iliac or caval thrombosis will be randomly assigned to receive either dalteparin using the CLOT regimen or to oral rivaroxaban using the conventional dosage given in the Einstein studies. Experimental and control treatments will be given for three months. The main outcome at three month will include all symptomatic and incidentally discovered venous thromboembolic events including pulmonary embolism (either objectively confirmed and death due to pulmonary embolism), lower limb and upper limb deep vein thrombosis, iliac, caval and visceral thrombosis and any worsening of vascular obstruction which will be collected systematically at inclusion and at day 90. The safety end-points will consist of the rate of major bleedings and the composite of major and non-major but clinically significant bleedings at day 90. All outcome events will be blindly adjudicated by a central independent adjudication committee.

Being tested
rivaroxaban, Low-molecular-weight heparin
Keywords
cancer, venous thromboembolism, low-molecular weight heparin, rivaroxaban
Medical subject headings
Neoplasms, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rivaroxabanDrug

    Also called xarelto

    rivaroxaban, 15 mg BD (Bis in die) for 3 weeks followed by 20mg OD (Omni die) for 9 weeks

  • Low-molecular-weight heparinDrug

    Also called dalteparin

    dalteparin, 200 IU/kg OD for 4 weeks followed by 150 IU/kg OD for 8 weeks

Study groups in NCT02746185
Study groupRoleWhat they receive
Low-molecular-weight heparinActive comparatordalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months
Receives: Drug: Low-molecular-weight heparin
RivaroxabanExperimentalrivaroxaban, orally, 15 mg twice daily for 3 weeks followed by 20 mg once daily for 9 weeks
Receives: Drug: rivaroxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic DVT

    Recurrent VTE during the 3-month treatment period including all symptomatic DVT (lower limbs distal and proximal DVTs, iliac and caval thrombosis, visceral thrombosis and deep vein thrombosis of the arm)

    Measured: 3 months

  2. Symptomatic PE

    Recurrent VTE during the 3-month treatment period including symptomatic PE

    Measured: 3 months

  3. Unsuspected PE and DVT

    Recurrent VTE during the 3-month treatment period including clinically unsuspected PE and DVT discovered incidentally

    Measured: 3 months

  4. Worsening of pulmonary vascular or venous obstruction

    Recurrent VTE during the 3-month treatment period including worsening of pulmonary vascular obstruction or venous obstruction on the systematic examinations performed at the end of the 3-month treatment period

    Measured: 3 months

Secondary outcomes (4)

  1. Major and clinically significant bleedings during the 3-month treatment period

    Major bleeding is defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and includes any bleeding resulting in death; symptomatic bleeding in a critical organ including intracranial, intra spinal, intraocular, retroperitoneal, intra articular and pericardial bleeding and muscle bleeding resulting in compartment syndrome; symptomatic bleeding resulting in a decrease in the hemoglobin concentration of at least 2g/dL or resulting in the transfusion of at least two packs of blood red cells.

    Measured: 3 months

  2. Symptomatic recurrences of PE or DVT of the legs

    excluding visceral thrombosis, upper extremity deep vein thrombosis and clinically unsuspected PE and DVT diagnosed incidentally

    Measured: 3 months

  3. Major and non-major clinically significant bleedings at day 90

    Clinically significant non-major bleedings are defined as any bleeding requiring hospitalization or a medical intervention including temporary withholding of anticoagulant treatment to stop bleeding.

    Measured: 3 months

  4. Mortality

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion25 Apr 2018
  4. Study completion25 Apr 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02746185
Sponsor's protocol ID
P141204
Acronym
CASTA-DIVA
Status last verified
Aug 2018
First submitted
15 Dec 2015
Last updated
13 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Planquette B, Bertoletti L, Charles-Nelson A, Laporte S, Grange C, Mahe I, Pernod G, Elias A, Couturaud F, Falvo N, Sevestre MA, Ray V, Burnod A, Brebion N, Roy PM, Timar-David M, Aquilanti S, Constans J, Bura-Riviere A, Brisot D, Chatellier G, Sanchez O, Meyer G, Girard P, Mismetti P; CASTA DIVA Trial Investigators. Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial. Chest. 2022 Mar;161(3):781-790. doi: 10.1016/j.chest.2021.09.037. Epub 2021 Oct 8.

    PubMed 34627853

  • Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.

    PubMed 34172290

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rivaroxaban and Low-molecular-weight heparin in people with Neoplasm and Venous Thromboembolism, run by Assistance Publique - Hôpitaux de Paris at 15 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Symptomatic DVT (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02746185, which also lists 2 linked publications.

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 13 Aug 2018.

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