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Summary

for people ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

Official Title

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

Details

Venous blood clots affect nearly a million Americans each year. Venous clots in the legs are called deep venous thrombosis (DVT) and are dangerous because they travel to the lungs where they cause blockages known as pulmonary emboli (PE). DVT and PE are called venous thromboemboli (VTE). Cancer is a risk factor with nearly 200,000 VTEs in cancer patients each year. The purpose of VTE treatment is to prevent the initial clot from spreading and to prevent new clots from forming. This is accomplished by thinning the blood, or anticoagulation. Without anticoagulation, VTEs recur and are often fatal.

Recently, the FDA has approved 4 new Direct Oral AntiCoagulants (DOACs) for preventing VTE recurrence. Few cancer patients were included in the efficacy trials, and practice guidelines fall silent on whether switching to DOAC therapy is advisable. To fill this knowledge gap, the Alliance Foundation Trials LLC, a research network of academic and community practices across the US, is conducting a pragmatic randomized effectiveness trial.

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The investigators will conduct a trial of 940 cancer patients followed for 6 months. The intervention strategy is DOAC therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is LMWH alone or with warfarin. Within each arm, patients can choose the agent they prefer based on side effects, drug interactions, and practical issues such as co-pays. The trial compares these two strategies in terms of treatment: 1) benefits based on VTE recurrence; 2) harms based on bleeding rates; 3) burdens based on patients' reports of their experiences; and 4) mortality rates.

The investigators hypothesize that the benefits, harms and burdens of DOAC treatment will be non-inferior to, or better than, usual care with LMWH/ warfarin among cancer patients. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

Keywords

Cancer Venous Thromboembolism Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Blood Clot Rivaroxaban (Xarelto) Apixaban (Eliquis) Edoxaban (Savaysa) Dabigatran (Pradaxa) Warfarin (Coumadin) Low molecular weight heparin (LMWH) Thrombosis Thromboembolism Embolism Pulmonary Embolism Venous Thrombosis Apixaban Edoxaban Fondaparinux PENTA Heparin Warfarin Rivaroxaban Dabigatran Anticoagulants Heparin, Low-Molecular-Weight Dalteparin

Eligibility

You can join if…

Open to people ages 21 years and up

  • Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma<= 12 months prior to study enrollment
  • Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms
  • Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
  • Treating physician intends to put participant on anticoagulation therapy for at least three months.
  • Age >= 21 years
  • Platelet count is >= 50,000/mm3 (<= 7 days prior to enrollment)

  • CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)

You CAN'T join if...

  • Diagnosis of acute leukemia
  • Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
  • Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
  • Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
  • Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
  • Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
  • Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment

Locations

  • UCSF Medical Center - Mission Bay accepting new patients
    San Francisco, California, 94143, United States
  • MultiCare Regional Cancer Center - Puyallup accepting new patients
    Puyallup, Washington, 98372, United States
  • Multicare Institute for Research & Innovation accepting new patients
    Tacoma, Washington, 98405, United States
  • MultiCare Regional Cancer Center - Tacoma accepting new patients
    Tacoma, Washington, 98405, United States
  • MultiCare Regional Cancer Center - Auburn accepting new patients
    Auburn, Washington, 98001, United States
  • MultiCare Regional Cancer Center - Gig Harbor Medical Park accepting new patients
    Gig Harbor, Washington, 98335, United States
  • Community Hospital of Anaconda accepting new patients
    Anaconda, Montana, 59711, United States
  • Kootenai Health accepting new patients
    Post Falls, Idaho, 83854, United States
  • Community Medical Center accepting new patients
    Missoula, Montana, 59804, United States
  • Bozeman Health accepting new patients
    Bozeman, Montana, 59715, United States
  • Kalispell Regional Medical Center accepting new patients
    Kalispell, Montana, 59901, United States
  • Montana Cancer Consortium accepting new patients
    Billings, Montana, 59102, United States
  • Billings Clinic accepting new patients
    Billings, Montana, 59101, United States
  • Benefis Sletten Cancer Institute accepting new patients
    Great Falls, Montana, 59405, United States
  • Baylor Scott & White Research Institute accepting new patients
    Dallas, Texas, 75204, United States
  • Baylor University Medical Center accepting new patients
    Dallas, Texas, 75246, United States
  • Ellis Fischel Cancer Center University of Missouri Healthcare accepting new patients
    Columbia, Missouri, 65212, United States
  • Veterans Administration/Harry S Truman Memorial Hospital accepting new patients
    Columbia, Missouri, 65201, United States
  • Siteman Cancer Center - St. Peters accepting new patients
    Saint Peters, Missouri, 63376, United States
  • Siteman Cancer Center - West County accepting new patients
    Saint Louis, Missouri, 63141, United States
  • Siteman Cancer Center - South County accepting new patients
    Saint Louis, Missouri, 63129, United States
  • Washington University School of Medicine accepting new patients
    Saint Louis, Missouri, 63110, United States
  • University of Wisconsin accepting new patients
    Madison, Wisconsin, 53792, United States
  • Carle - Effingham accepting new patients
    Effingham, Illinois, 62401, United States
  • Carle on Vermillion accepting new patients
    Danville, Illinois, 61938, United States
  • Carle - Mattoon/Charleston accepting new patients
    Mattoon, Illinois, 61938, United States
  • Green Bay Oncology, Ltd./Door County Memorial Hospital accepting new patients
    Sturgeon Bay, Wisconsin, 54135, United States
  • The Carle Foundation Hospital/Carle Cancer Center accepting new patients
    Urbana, Illinois, 61801, United States
  • Medical College of Wisconsin accepting new patients
    Milwaukee, Wisconsin, 53226, United States
  • Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center accepting new patients
    Green Bay, Wisconsin, 54303, United States
  • HSHS St. Mary's Hospital Medical Center accepting new patients
    Green Bay, Wisconsin, 54303, United States
  • Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital accepting new patients
    Oconto Falls, Wisconsin, 54154, United States
  • NorthShore University HealthSystem Highland Park Hospital accepting new patients
    Highland Park, Illinois, 60035, United States
  • NorthShore University HealthSystem Glenbrook Hospital accepting new patients
    Glenview, Illinois, 60026, United States
  • Green Bay Oncology, Ltd./HSHS St. Vincent Hospital accepting new patients
    Green Bay, Wisconsin, 54301, United States
  • HSHS St. Vincent Hospital accepting new patients
    Green Bay, Wisconsin, 54301, United States
  • NorthShore University HealthSystem Skokie ACC accepting new patients
    Skokie, Illinois, 60076, United States
  • NorthShore University HealthSystem Evanston Hospital accepting new patients
    Evanston, Illinois, 60201, United States
  • Green Bay Oncology, Ltd./St. Francis Hospital accepting new patients
    Escanaba, Michigan, 49829, United States
  • James Graham Brown Cancer Center accepting new patients
    Louisville, Kentucky, 40202, United States
  • Norton Hospital accepting new patients
    Louisville, Kentucky, 40202, United States
  • University of Louisville Hospital accepting new patients
    Louisville, Kentucky, 40202, United States
  • University of Louisville Physicians, PSC accepting new patients
    Louisville, Kentucky, 40202, United States
  • University of Louisville, Division of Surgical Oncology accepting new patients
    Louisville, Kentucky, 40202, United States
  • Reid Health accepting new patients
    Richmond, Indiana, 47374, United States
  • Dayton Physicians, Wayne accepting new patients
    Greenville, Ohio, 45331, United States
  • Dayton Physicians LLC, Samaritan North accepting new patients
    Dayton, Ohio, 45415, United States
  • Dayton Physicians LLC, Atrium accepting new patients
    Franklin, Ohio, 45005, United States
  • Chandler Medical Center - University of Kentucky accepting new patients
    Lexington, Kentucky, 40536, United States
  • Dayton Physicians LLC, Upper valley accepting new patients
    Troy, Ohio, 45373, United States
  • Greater Dayton Cancer Center accepting new patients
    Kettering, Ohio, 45409, United States
  • Dayton Physicians LLC, Miami Valley South accepting new patients
    Centerville, Ohio, 45459, United States
  • Kettering Medical Center accepting new patients
    Kettering, Ohio, 45429, United States
  • Dayton Clincial Oncology Program accepting new patients
    Dayton, Ohio, 45420, United States
  • Wright Patterson Medical Center accepting new patients
    Dayton, Ohio, 45433, United States
  • Toledo Clinic Cancer Center - Maumee accepting new patients
    Maumee, Ohio, 43537, United States
  • Toledo Clinic Cancer Center - Toledo accepting new patients
    Toledo, Ohio, 43623, United States
  • Henry Ford Health System accepting new patients
    Detroit, Michigan, 48202, United States
  • The James Cancer Hospital and Solove Research Institute accepting new patients
    Columbus, Ohio, 43210, United States
  • Western Pennsylvania Hospital accepting new patients
    Pittsburgh, Pennsylvania, 15224, United States
  • Wake Forest Baptist Health accepting new patients
    Winston-Salem, North Carolina, 27157, United States
  • Roswell Park Cancer Institute accepting new patients
    Buffalo, New York, 14263, United States
  • Augusta Health Cancer Center accepting new patients
    Fishersville, Virginia, 22939, United States
  • Morton Plant Hospital accepting new patients
    Clearwater, Florida, 33756, United States
  • Duke University Health System accepting new patients
    Durham, North Carolina, 27710, United States
  • Hollis Cancer Center accepting new patients
    Lakeland, Florida, 33805, United States
  • WellSpan Health Adams Cancer Center accepting new patients
    Gettysburg, Pennsylvania, 17325, United States
  • Bon Secours Cancer Institute Medical Oncology at St. Francis accepting new patients
    Midlothian, Virginia, 23114, United States
  • Southeastern Medical Oncology Center accepting new patients
    Clinton, North Carolina, 28328, United States
  • Bon Secours Cancer Institute Medical Oncology at St. Mary's accepting new patients
    Richmond, Virginia, 23226, United States
  • Bon Secours Cancer Institute Medical Oncology at Memorial Regional accepting new patients
    Mechanicsville, Virginia, 23116, United States
  • Southeastern Medical Oncology Center accepting new patients
    Goldsboro, North Carolina, 27534, United States
  • WellSpan Health York Cancer Center accepting new patients
    York, Pennsylvania, 17403, United States
  • SUNY Upstate Medical University accepting new patients
    New York, New York, 13210, United States
  • Kenansville Medical Center accepting new patients
    Kenansville, North Carolina, 28349, United States
  • University of Maryland Medical Center accepting new patients
    Baltimore, Maryland, 21201, United States
  • WellSpan Health Sechler Family Cancer Center accepting new patients
    Lebanon, Pennsylvania, 17042, United States
  • Kinston Medical Specialists, P.A. accepting new patients
    Kinston, North Carolina, 28501, United States
  • Lenoir Memorial Hospital accepting new patients
    Kinston, North Carolina, 28501, United States
  • East Carolina University accepting new patients
    Greenville, North Carolina, 27834, United States
  • WellSpan Health Ephrata Cancer Center accepting new patients
    Ephrata, Pennsylvania, 17522, United States
  • Onslow Medical Center accepting new patients
    Richlands, North Carolina, 28574, United States
  • Southeastern Medical Oncology Center accepting new patients
    Jacksonville, North Carolina, 28546, United States
  • Breast Cancer Center at Memorial Hospital West accepting new patients
    Pembroke Pines, Florida, 33028, United States
  • Memorial Cancer Institute at Memorial Hospital West accepting new patients
    Pembroke Pines, Florida, 33028, United States
  • Memorial Hospital West accepting new patients
    Pembroke Pines, Florida, 33028, United States
  • Breast Cancer Center at Memorial Regional Hospital accepting new patients
    Hollywood, Florida, 33021, United States
  • Memorial Cancer Institute at Memorial Regional Hospital accepting new patients
    Hollywood, Florida, 33021, United States
  • Memorial Regional Hospital accepting new patients
    Hollywood, Florida, 33021, United States
  • Hackensack University Medical Center accepting new patients
    Hackensack, New Jersey, 07601, United States
  • John Theurer Cancer Center at Hackensack University Medical Center accepting new patients
    Hackensack, New Jersey, 07601, United States
  • University of Vermont Medical Center accepting new patients
    Burlington, Vermont, 05401, United States
  • The Stamford Hospital accepting new patients
    Stamford, Connecticut, 06904, United States
  • Middlesex Hospital accepting new patients
    Middletown, Connecticut, 06457, United States
  • Dartmouth Hitchcock Medical Center accepting new patients
    Lebanon, New Hampshire, 03756, United States
  • DF/BWCC at Milford Regional Medical Center accepting new patients
    Boston, Massachusetts, 01757, United States
  • Dana-Farber/New Hampshire Oncology Hematology accepting new patients
    Londonderry, New Hampshire, 03053, United States
  • Lowell General Hospital accepting new patients
    Lowell, Massachusetts, 01854, United States
  • St. Elizabeth's Medical Center accepting new patients
    Brighton, Massachusetts, 02135, United States
  • Dana-Farber Cancer Institute accepting new patients
    Boston, Massachusetts, 02215, United States
  • Brigham & Women's Hospital accepting new patients
    Boston, Massachusetts, 02115, United States
  • Massachusetts General Hospital accepting new patients
    Boston, Massachusetts, 02114, United States
  • South Shore Hospital accepting new patients
    South Weymouth, Massachusetts, 02190, United States
  • Eastern Maine Medical Center accepting new patients
    Bangor, Maine, 04401, United States
I’m interested in this study!