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

Primary Purpose

Urothelial Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravesical 2000mg/52.6ml gemcitabine instillation
Normal saline
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urothelial Carcinoma

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cancer CenterRecruiting
  • Asan Medical CenterRecruiting
  • Korea University Anam HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal saline

Gemcitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
International Prostate Symptom Score questionnaire at one week after surgery.
Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery

Full Information

First Posted
February 15, 2017
Last Updated
April 6, 2022
Sponsor
National Cancer Center, Korea
Collaborators
Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Chong Kun Dang Pharmaceutical Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT03062059
Brief Title
The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Chong Kun Dang Pharmaceutical Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Intravesical 52.6ml normal saline instillation during radical nephroureterectomy followed by normal saline bladder irrigation
Arm Title
Gemcitabine
Arm Type
Experimental
Arm Description
Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy followed by normal saline bladder irrigation
Intervention Type
Drug
Intervention Name(s)
Intravesical 2000mg/52.6ml gemcitabine instillation
Other Intervention Name(s)
Gem Tan inj (liquid)
Intervention Description
Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Primary Outcome Measure Information:
Title
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.
Description
Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine
Time Frame
Two years
Secondary Outcome Measure Information:
Title
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.
Description
Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence
Time Frame
six years
Title
Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Description
Analysis of survival status due to any cause at six years from intravesical instillation of 2000mg/52.6ml gemcitabine
Time Frame
six years
Title
CT cystography finding at one week after surgery.
Description
Evaluation of leakage at CT cystography at one week from intravesical instillation of 2000mg/52.6ml gemcitabine
Time Frame
one week
Title
International Prostate Symptom Score questionnaire at one week after surgery.
Description
Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Kyung Seo, M.D.
Phone
82-31-920-1678
Email
seohk@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon Seok Suh, M.D.
Phone
82-10-5019-9807
Email
12754@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok Ho Kang, M.D.
Organizational Affiliation
Korea universitiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Kyung Seo, M.D.
First Name & Middle Initial & Last Name & Degree
Jinsoo Chung, M.D.
First Name & Middle Initial & Last Name & Degree
Sung Han Kim, M.D.
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bum Sik Hong, M.D.
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok Ho Kang, M.D.
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byong Chang Jeong, M.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ja Hyun Ku, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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