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

JRCT ID: jRCTs031180124

Registered date:14/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gynecological cancer
• Date of first enrollment: 15/11/2017
• Target sample size: 96
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

Primary Outcome

[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

Secondary Outcome

[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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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) Over 20 years old at written informed consent.
(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(Exclude patients who had symptoms previously).

Exclude 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).

Related Information

• Primary Sponsor: Fujiwara Hiroyuki
• Secondary Sponsor: Gynecologic Oncology Trial and Investigation Consortium
• Secondary ID(s): UMIN000026886