The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Urothelial Carcinoma

Treatments: Drug: Intravesical 2000mg/52.6ml gemcitabine instillation; Other: Normal saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03062059

InstiGem

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.

Full description

Study Design: Intervention Model: Single Group Assignment

Masking: Open Label

Primary Outcome Measures:

Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.

Secondary Outcome Measures:

Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.

Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.

Safety of intravesical 2000mg/52.6ml gemcitabine instillation.

Enrollment: 134 estimated patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects who will undergo nephroureterectomy due to ureter or renal pelvis urothelial carcinoma
• Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as upper urinary tract urothelial carcinoma
• Normal bone marrow function: Hemoglobin >10 g/dL, ANC >1,500/mm3, platelet count>100,000/mm3
• Normal bladder volume and function
• Normal liver function:
• Bilirubin ≤ 1.5 times of upper normal limit
• AST/ALT ≤ 1.8 times of upper normal limit
• Alkaline phosphatase ≤ 1.8 times of upper normal limit
• Subjects who voluntarily decided to participate and signed the written informed consent

Exclusion criteria

• Concomitant bladder cancer
• Subjects who underwent any treatment due to bladder cancer within 3 years
• Prior hypersensitivity reaction history to gemcitabine
• Neurogenic bladder
• Subjects who underwent chemotherapy due to any cancer within 6 months
• Subjects who underwent neoadjuvant chemotherapy due to ureter or renal pelvis urothelial carcinoma
• Hypersensitivity to gemcitabine or component of gemcitabine
• In case of co-administration of gemcitabine and cisplatin in severe renal failure patients
• Moderate to severe liver dysfunction or renal dysfunction (Glomerular filtration rate < 30 mL/min)
• Severe bone marrow suppression
• Severe infection
• Female who are pregnant or has a possibility of pregnancy
• Nursing female
• Interstitial pneumonia or pulmonary fibrosis which is evident on chest x-ray and symptomatic
• Subjects who are undergoing radiotherapy on chest

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

Intravesical 52.6ml normal saline instillation during radical nephroureterectomy followed by normal saline bladder irrigation

Treatment:

Other: Normal saline

Gemcitabine

Experimental group

Description:

Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy followed by normal saline bladder irrigation

Treatment:

Drug: Intravesical 2000mg/52.6ml gemcitabine instillation