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Trial record 25 of 26 for:    upper tract urothelial

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

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ClinicalTrials.gov Identifier: NCT03062059
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : September 18, 2017
Sponsor:
Collaborators:
Samsung Medical Center
Asan Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
Ho Kyung Seo, National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Intravesical 2000mg/52.6ml gemcitabine instillation Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
No Intervention: Control arm
Experimental: Intervention arm
Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy
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




Primary Outcome Measures :
  1. 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. [ Time Frame: Two years ]
    Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine


Secondary Outcome Measures :
  1. 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. [ Time Frame: six years ]
    Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence

  2. Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. [ Time Frame: six years ]
    Analysis of survival status due to any cause at six years from intravesical instillation of 2000mg/52.6ml gemcitabine

  3. CT cystography finding at one week after surgery. [ Time Frame: one week ]
    Evaluation of leakage at CT cystography at one week from intravesical instillation of 2000mg/52.6ml gemcitabine

  4. International Prostate Symptom Score questionnaire at one week after surgery. [ Time Frame: one week ]
    Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062059


Contacts
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Contact: Ho Kyung Seo, M.D. 82-31-920-1678 seohk@ncc.re.kr
Contact: Yoon Seok Suh, M.D. 82-10-5019-9807 12754@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center Recruiting
Goyang, Korea, Republic of
Contact: Ho Kyung Seo, M.D.         
Sub-Investigator: Jinsoo Chung, M.D.         
Sub-Investigator: Sung Han Kim, M.D.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Bum Sik Hong, M.D.         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seok Ho Kang, M.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Byong Chang Jeong, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ja Hyun Ku, M.D.         
Sponsors and Collaborators
National Cancer Center, Korea
Samsung Medical Center
Asan Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Chong Kun Dang Pharmaceutical Corp.

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Responsible Party: Ho Kyung Seo, Primary Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03062059     History of Changes
Other Study ID Numbers: InstiGem
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs