Urothelial CarcinomaPhase 2NCT03062059
The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
A Phase 2 study testing Intravesical 2000mg/52.6ml gemcitabine instillation and Normal saline in people with Urothelial Carcinoma, run by National Cancer Center, Korea at 5 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Intravesical 2000mg/52.6ml gemcitabine instillation and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 1 Mar 2018to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center
Goyang
Ho Kyung Seo, M.D.
Jinsoo Chung, M.D.
- Recruiting
Asan Medical Center
Seoul
Bum Sik Hong, M.D.
- Recruiting
Korea University Anam Hospital
Seoul
Seok Ho Kang, M.D.
- Recruiting
Samsung Medical Center
Seoul
Byong Chang Jeong, M.D.
- Recruiting
Seoul National University Hospital
Seoul
Ja Hyun Ku, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- Intravesical 2000mg/52.6ml gemcitabine instillation, Normal saline
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical 2000mg/52.6ml gemcitabine instillationDrug
Also called Gem Tan inj (liquid)
Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Normal salineOther
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Intravesical 52.6ml normal saline instillation during radical nephroureterectomy followed by normal saline bladder irrigation Receives: Other: Normal saline |
| Gemcitabine | Experimental | Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy followed by normal saline bladder irrigation Receives: Drug: Intravesical 2000mg/52.6ml gemcitabine instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence
Measured: six years
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
Measured: six years
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
Measured: one week
International Prostate Symptom Score questionnaire at one week after surgery.
Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Chong Kun Dang Pharmaceutical Corp.
- Responsible party
- Principal investigator, Ho Kyung Seo, National Cancer Center, Korea
- Investigators
- Seok Ho Kang, M.D., Principal investigator, Korea universitiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062059
- Sponsor's protocol ID
- InstiGem
- Status last verified
- Apr 2022
- First submitted
- 15 Feb 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03062059
- Acronym / sponsor ID
- InstiGem
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Chong Kun Dang Pharmaceutical Corp.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Other: Normal salineIntravesical 52.6ml normal saline instillation during radical nephroureterectomy followed by normal saline bladder irrigation |
| Gemcitabine | Experimental | Drug: Intravesical 2000mg/52.6ml gemcitabine instillationIntravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy followed by normal saline bladder irrigation |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical 2000mg/52.6ml gemcitabine instillationAlso: Gem Tan inj (liquid)Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma | Drug | Gemcitabine |
| Normal salineIntravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma | Other | Normal saline |
Primary outcome
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
4 secondary outcomes
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
Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Time frame: six years
CT cystography finding at one week after surgery.
Time frame: one week
International Prostate Symptom Score questionnaire at one week after surgery.
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok Ho Kang, M.D. principal investigator
Korea universitiy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravesical 2000mg/52.6ml gemcitabine instillation and Normal saline in people with Urothelial Carcinoma, run by National Cancer Center, Korea at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Kyung Seo, M.D. (82-31-920-1678, seohk@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.