An observational study for incidence of thromboembolism in lung cancer patients.

Not Applicable

• Conditions: on-small cell lung cancer, small cell lung cancer

• Registration Number: JPRN-jRCTs061180025
• Lead Sponsor: ISOBE Takeshi

Brief Summary

we conclude attention should be paid to VTE during treatment for lung cancer. Second, treatment with edoxaban was highly effective in preventing recurrence of VTE, but treatment should be considered more carefully because of the high bleeding possibility.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Study Completion: 2020-08-12
• Results First Posted: 2022-07-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1021

Inclusion Criteria

1)Pathologically or cytologically diagnosed non-small-cell or small cell lung cancer.
2)ECOG PS 0-3.
3)Age over 20 years old.
4)It satisfies one of the following.
Small cell lung cancer of ED-stage.
Non-small-cell lung cancer of stage IIIB or IV.
Reccurence of operation or concurrent chemoradiotherapy.
Best supportive care patient.
5)6 months or longer expected survival.
6)Written informed consent.

Exclusion Criteria

1)History of allergic reaction for edoxavan.
2)Severe renal dysfunction. (Ccr under 30 mL/min)
3)Severe liver disease.
4)Interstitial pneumonia.
5)Plannning for concurrent chemoradiotherapy.
6)Started medication or treatment for VTE.
7)More than 48 hours of anticoagulant (LMWH, UFH, fondaparinux or VKA, Edoxaban etc) was administered to the most recently diagnosed VTE.
8)ALT is more than twice the facility reference value or T-Bil is more than 1.5 times the facility reference value.
9)Active bleeding.
10)Severe hypertention.
11)A pregnant woman, a woman in breast-feeding.
12)Taking aspirin or two kind os antiplatelet drug.
13)Acute infectious endocarditis.
14)An inappropriate case judged by doctor in charge.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VTE noncompliant group (observation group): Symptomatic VTE incidence rate in 2 years after this study registration.<br> VTE merger group (treatment intervention group): symptomatic / asymptomatic VTE relapse rate for 6 months after start of oral administration of Edoxaban.