NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Non-muscle invasive bladder carcinoma
Date of first enrollment	01/10/2010
Target sample size	6
Countries of recruitment
Study type	INTERVENTIONAL
Intervention(s)	Intervention name : EO9 Dosage And administration of the intervention : Intravesical Instillation Control intervention name : null

Outcome(s)

Primary Outcome	Safety
Secondary Outcome	Pharmacokinetics

Key inclusion & exclusion criteria

Age minimum	20
Age maximum	74
Gender	BOTH
Include criteria	(1) Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder and satisfy both of the following criteria: The maximum number of tumors is 5. Tumor diameter:< 3.5 cm. (2) The functions of the major organs are adequate, and the following test value criteria are satisfied. (These tests will be performed within 4 weeks prior to the present TURBT.) WBC count >-3,000 /uL Platelet count >-10x104 /uL AST, ALT <2.5 times the institutional upper limit of normal Total bilirubin <1.5 times the institutional upper limit of normal Serum creatinine -<1.5 mg /dL Hemoglobin >-9.5 g/dL
Exclude criteria	(1) Patients with a primary and solitary tumor. (2) CIS lesions in the bladder or a history thereof. (3) Grade 3 disease or a history thereof. (4) Patients experiencing recurrence within 3 months following TURBT for prior NMIBC. (5) Patients having stage T1 and high-grade disease. (6) Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof. (7) Patients who received intravesical chemotherapy treatment within 6 months prior to the present TURBT.