UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028517
Receipt number R000027726
Scientific Title A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy. (ExCAVE study)
Date of disclosure of the study information 2017/08/22
Last modified on 2021/11/15 14:15:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy.
(ExCAVE study)

Acronym

ExCAVE study

Scientific Title

A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy.
(ExCAVE study)

Scientific Title:Acronym

ExCAVE study

Region

Japan


Condition

Condition

Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of edoxaban for treatment of incidental asymptomatic VTE in gastrointestinal cancer patients receiving chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of major bleeding and clinically relevant non-major bleeding during 3 months after enrollment. Major bleeding events included those that were fatal; occurred in a critical area or organ (eg, intracranial); or caused a fall in hemoglobin of 2 g/dL or more or led to a transfusion of 2 or more units of whole blood or red cells. All non-major bleeding events that required any medical or surgical intervention were classified as clinically relevant non-major bleeding.

Key secondary outcomes

Diminution rate of VTE during 3 months after enrollment.
Time to diminution of VTE
Total amounts of edoxaban
Incidence of newly symptomatic/asymptomatic VTE
Subgroup analysis: Site of TE, dose of edoxaban, site of primary cancer, renal function, body weight, age


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The edoxaban (Lixiana) is orally administered as a once-daily dosing within three days before enrollment. The once-daily starting dose is 60mg.For patients with one or more factors that increase the risk of bleeding, such as renal impairment (CrCl 15-50mL.min), low body weight (under 60 kg), concomitant use of P-gp inhibitors (e.g. cyclosporine, dronedarone, ketoconazole, erythromycin), the dose is reduced by half.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed adenocarcinoma in colorectal or non-colorectal cancers, including esophageal, gastric, pancreatic, and biliary cancer.
2) Newly diagnosed, incidental, asymptomatic deep-vein thrombosis involving the popliteal, femoral, or iliac veins or asymptomatic pulmonary embolism during GIC chemotherapy.
3) Identified with no VTE cases at the time of induction of chemotherapy by pre-screening test.
4) Patients 20 years of age or older and 90 years or younger are eligible at the time of informed consent.
5) Written informed consent to participate as a subject in this clinical study.
6) The following bone marrow, liver, and kidney function parameters measured within 14 days prior to enrollment:
i) Neutrophil count: over 1500/uL
ii) Platelet count: over 75000/uL
iii) Hemoglobin: over 7.0 g/dL
iv) Total bilirubin: under 1.5 mg/dL
v) AST,ALT levels: under 2xULN
vi) serum creatinine levels: < 1.5 mg/dL
7) ECOG PS of 0 to 2
8) Life expectancy of at least 90 days after enrollment

Key exclusion criteria

1) Symptomatic VTE or PE at the time of diagnosed.
2) Patients who had received thrombectomy,IVC filter catheterization, and any other anticoagulant therapy.
3) In investigator's decision that the case need to be treated as acute VTE.
4) No prior screening tests for the presence of venous thromboembolic disease was performed, such as computer tomography and/or venous ultrasonography.
5) Planned treatment with a vitamin K antagonist.
6) Patients who had received treatment for more than 72 hours with therapeutic doses of heparin, low-molecular-weight heparin, more than twice dose of a vitamin K antagonist.
7) Active bleeding
8) Having several high risk factor of VTE within 3 months.
9) Known protein C or S deficiency, antithrombin deficiency, hyperhomocysteinemia, and anti-phospholipid antibody syndrome.
10) Severe hypertension which have poorly controlled despite the medication.
11) continued to receive treatment with NSAIDs except an aspirin at a dose of more than four days a week.
12) continued to receive treatment with aspirin at a dose of more than 100mg daily or dual antiplatelet therapy.
13) contined to receive treatment with dronedarone.
14) Renal dysfunction (CCR under 30mL/min)
15) Accumulation of pleural, ascitic, or pericardial fluid requiring drainage
16) Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure). Any of the following events within the 24 weeks prior to enrollment.
17) Serious hypersensitivity to any drug.
18) Current severe liver disease.
19) Active infection and/or inflammatory diseases.
20) Severe cardiac failure (over NYHA II)
21) Ineligible for participating in this study according to the investigator.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshito
Middle name
Last name Komatsu

Organization

Hokkaido University Hospital

Division name

Cancer Center

Zip code

060-8648

Address

Kita-15-Jo, Nishi-5-chome, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-716-1161

Email

ykomatsu@ac.cyberhome.ne.jp


Public contact

Name of contact person

1st name Michio
Middle name
Last name Nakamura

Organization

Sapporo City General Hospital

Division name

Dept. of Gastroenterology

Zip code

060-8604

Address

1-1, Kita 11 jo Nishi 13 Chome, Chuo-ku, Sapporo, JAPAN

TEL

011-726-2211

Homepage URL


Email

michio.nakamura@icloud.com


Sponsor or person

Institute

HGCSG(Hokkaido Gastrointestinal Cancer Study Group)

Institute

Department

Personal name



Funding Source

Organization

Daiichi-Sankyo, Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Certified Review Board

Address

Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7934

Email

recjimu@huhp.hokudai.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

jRCTs011180030

Org. issuing International ID_1

Japan Registry of Clinical Trials

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

特定非営利活動法人 北海道消化器癌化学療法研究会(HGCSG)


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 06 Month 23 Day

Date of IRB

2017 Year 08 Month 23 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 03 Day

Last modified on

2021 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027726


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name