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

NCT03062059 | Unknown Phase 2

• 1 other identifier: InstiGem
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 5

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (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.

  Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine

  Two years

Secondary Outcomes (4)

• 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.

  six years

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

  six years

• CT cystography finding at one week after surgery.

  one week

• International Prostate Symptom Score questionnaire at one week after surgery.

  one week

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

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

Other: Normal saline

Gemcitabine

EXPERIMENTAL

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

Drug: Intravesical 2000mg/52.6ml gemcitabine instillation

Interventions

Intravesical 2000mg/52.6ml gemcitabine instillation DRUG

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

Also known as: Gem Tan inj (liquid)

Gemcitabine

Normal saline OTHER

Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma

Normal saline

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Chong Kun Dang Pharmaceutical Corp.: collaborator

Study Sites (5)

National Cancer Center

Goyang, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Fluid Therapy; Saline Solution

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Seok Ho Kang, M.D.

  Korea universitiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Kyung Seo, M.D.

CONTACT

82-31-920-1678; seohk@ncc.re.kr

Yoon Seok Suh, M.D.

CONTACT

82-10-5019-9807; 12754@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)