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

Urothelial Carcinoma Clinical Trial

Official title:

The Effectiveness and Safety of Intravesical Gemcitabine Instillation During Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy in Upper Urinary Tract Urothelial Carcinoma: Prospective, Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062059
• Other study ID #: InstiGem
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: National Cancer Center, Korea
• Contact: Ho Kyung Seo, M.D.
• Phone: 82-31-920-1678
• Email: seohk[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Recurrence
• Urothelial Carcinoma

Intervention

Drug:
• Intravesical 2000mg/52.6ml gemcitabine instillation
Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma

Other:
• Normal saline
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Asan Medical Center, Chong Kun Dang Pharmaceutical Corp., Korea University Anam Hospital, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam.	Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine	Two years
Secondary	Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam.	Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence	six years
Secondary	Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.	Analysis of survival status due to any cause at six years from intravesical instillation of 2000mg/52.6ml gemcitabine	six years
Secondary	CT cystography finding at one week after surgery.	Evaluation of leakage at CT cystography at one week from intravesical instillation of 2000mg/52.6ml gemcitabine	one week
Secondary	International Prostate Symptom Score questionnaire at one week after surgery.	Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery	one week