UMIN-CTR Clinical Trial

Public title

A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism
in gynecological cancer patients.

Acronym

GOTIC-VTE trial/GOTIC-015

Scientific Title

A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism
in gynecological cancer patients.

Scientific Title:Acronym

GOTIC-VTE trial/GOTIC-015

Region

Japan

Condition

gynecological cancer

Classification by specialty

Obstetrics and Gynecology

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study is intended to clarify the actual condition of venous thromboembolism (VTE) in gynecological cancer patients and verify the superiority of perioperative long-term anticoagulation therapy for asymptomatic VTE patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[Registry part]
1) Base line
-Frequency of intercurrent of VTE at the time of VTE screening.

2) Observation period (one year)
-Incidence of symptomaticVTE
-Incidence of bleeding events

[Interventional part]
-Incidence of symptomatic PE during 28 days after surgery

Key secondary outcomes

[Registry part]
-Incidence of brain infarction/ systemic embolism
-Survival
-VTE related mortality rate and bleeding related mortality rate
-Brain infarction related mortality rate and systemic embolism related mortality rate

[Interventional part]
1) Incidence of symptomatic VTE (VTE, DVT, proximal DVT, distal DVT) for 28 days after surgery.
2) Incidence of bleeding events (MB, CRNMB, MB or CRNMB) for 28 days after surgery.
3) Incidence of HIT for 28 days after surgery.
4) VTE related mortality rate and bleeding related mortality rate for 28 days after surgery.
5) Incidence of symptomatic VTE (VTE, PE, DVT, proximal DVT, distal DVT) for 6 months after surgery.
6) Incidence of bleeding events (MB, CRNMB, MB or CRNMB) for 6 months after surgery.
7) Incidence of HIT for 6 months after surgery.
8) VTE related mortality rate and bleeding related mortality rate for 6 months after surgery.
9) survival
1.Overall survival: Period from registration to all-cause deaths.
2.Symptomatic VTE event-free survival: Period from registration to occurrence of symptomatic VTE.

10) Incidence of any adverse events that can't be denied relationship with the study drug or the protocol treatment from the protocol treatment start day to 30th day after the end of the protocol treatment
11) Incidence of any adverse events that can't be denied relationship with the study drug or the protocol treatment from the protocol treatment start day to 6 months after the end of the protocol treatment.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Perform anticoagulation therapy for 4 weeks postoperatively by switching from UFH to LMWH, Edoxaban for gynecological cancer patients who have founded asymptomatic VTE before surgery.

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Female

Key inclusion criteria

[Registry part]
(1) Over 20 years old at written informed consent.
(2) Diagnosed with endmetrial cancer,cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer(both initial and/or recurrence, but if final pathological diagnosis is benign tumors or borderline malignant tumors, it is excluded from the analysis.).
(3) Planned to undergo drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or surgery. For recurrence cases, patients who received drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or underwent surgery at initial occurrence can be enrolled.
(4) Carried out VTE screening (ultrasonography of the lower extremity veins (results of lower extremity contrast-enhanced CT within clinical practice is available)) within 2 months before enrollment (the same day of the week of 8 weeks before the registration date is available) and before the cancer treatment. If the D-dimer value within 2 months prior to registration is less than 1.2 microg/ml, it is acceptable even if VTE screening is not done (Treat as VTE not exist).

[Interventional part]
(1) Age at the time of written informed consent: 20 or older, 75 or younger.
(2) Initial patients diagnosed with endometrial carcinoma or cervical carcinoma (exclude carcinoma in situ), assumed to have epithelial ovarian, Fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis.
(3) Patients who founded DVT by lower extremities venous ultrasound or Lower Extremity contrast-enhanced CT within 2 months before enrollment (the same day of the week of 8 weeks before the registration date is available) and before the cancer treatment, or PE by thoracic contrast-enhanced CT.
(4) Patients who have searched for both DVT and PE.
(5) Patients without symptoms associated with VTE at the time of registration.

Key exclusion criteria

[Registry part]
(1) A patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with carcinoma in situ and intramucosal carcinoma are eligible for the study).
(2) A patient who is inappropriate as a subject of the study judged by investigator.

[Interventional part]
(1) Body weigh less than 40 kg.
(2) APTT value before the anticoagulation therapy starts prolonged more than 40 seconds.
(3) A patient who have not scheduled to undergo surgery during the initial treatment period.
(4) A patient who have already received anticoagulant therapy due to underlying diseases before diagnosing VTE ( A patient who have started some anticoagulant therapy after diagnosing VTE is available).
(5) A patient who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with carcinoma in situ and intramucosal carcinoma are eligible for the study).
(6) A patient with the following complications that may affect the conduct of this study and the evaluation of this study drug.

1) Bleeding lesion not due to gynecological cancer (including history of cerebrovascular disorder and subarachnoid hemorrhage within 6 months before registration) .
2) Uncontrolled hypertension.
3) Uncontrolled diabetes.
4) Suspicious of acute infective endocarditis.
5) Arterial embolism other than PE (including history).

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Fujiwara

Organization

Jichi Medical University

Division name

Depertment of obsterics and gynecology

Zip code

Address

3311-1 Yakushiji Shimotsuke city Tochigi

TEL

0285-58-7376

Email

fujiwara@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Mitsuko Mouri

Organization

Kanagawa Institute of Industrial Science and Technology

Division name

Global Health Research Coordinating Center

Zip code

Address

KSP East 3F 309, 3-2-1 Sakado Takatsu-ku Kawasaki

TEL

044-850-1731

Homepage URL

Email

gyn-vte@newkast.or.jp

Institute

GOTIC

Institute

Department

Personal name

Organization

Medical Science Department
Daiichi Sankyo Company, Limited.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

jRCTs031180124

Org. issuing International ID_1

Japan Registry of Clinical Trials

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

04

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

04

Month

05

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

04

Month

06

Day

Last modified on

2024

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029181