Urothelial CarcinomaPhase 2NCT03209206
The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence
A Phase 2 study testing Docetaxel in people with Urothelial Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC). Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Docetaxel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2017to 1 Apr 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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Upper urinary tract urothelial cell carcinoma
- Hb>10g/dL, ANC >1500mm3, Platelet > 100K
- Total bilirubin : 1.5 times lower than the normal upper limit
- AST/ALT: 1.8 times lower than the normal upper limit
- Alkaline phosphatase: 1.8 times lower than the normal upper limit
Who cannot join
- Concomitant bladder tumor
- Patients diagnosed with bladder cancer within the last 3 years
- Previous history of hypersensitivity to Docetaxel
- Neurogenic Bladder
- Patients who received chemotherapy for cancer within the last 6 months
- Patients with active disease not fit for this study
Show all 13Show fewer
- ANC <1500mm3
- Pregnant or lactating women
- Patients with severe hepatic dysfunction
- patients with severe renal impairment
- patients with hypersensitivity to mannitol, paraplatin, platinum compounds
- Patients with complications of infection
- Patients suspected of having infectious fever
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Ja Hyeon Ku, M.D, Ph.D, 82-2-2072-0361, randyku@hanmail.net
Bum Sik Tae, M.D, 82-2-2072-0361, bumsik4ever@hanmail.net
About this study
Official title: The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study
The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).
Read the detailed description
Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.
In this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.
- Conditions
- Urothelial Carcinoma
- Being tested
- Docetaxel, Placebo Normal saline
- Keywords
- Intravesical Chemotherapy, Docetaxel, Radical Nephroureterectomy
- 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.
DocetaxelDrug
Also called Instillation docetaxel after radical nephroureterectomy
Intravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
Placebo Normal salineDrug
Also called Instillation Normal saline after radical nephroureterectomy
Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel bladder instillation arm | Experimental | After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline) Receives: Drug: Docetaxel |
| Control arm | Placebo comparator | After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline) Receives: Drug: Placebo Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence in bladder
Present of bladder recurrence after intervention in follow up cystoscopy or CT scan
Measured: 2years
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events
Present of adverse event after intervention
Measured: 2years
Overall Survival
Overall Survival rate during follow up period
Measured: 2years
Time to recurrence
Time to bladder recurrence after intervention in follow up cystoscopy or CT scan
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start28 Jun 2017
- Primary completion19 Jun 2020 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Model description
- Prospective Randomized Phase II Trial
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ja Hyeon Ku, Seoul National University Hospital
- Investigators
- Ja Hyeon Ku, M.D.,PH.D, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209206
- Sponsor's protocol ID
- SeoulNUHUro
- Status last verified
- Dec 2017
- First submitted
- 30 Jun 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ito A, Shintaku I, Satoh M, Ioritani N, Aizawa M, Tochigi T, Kawamura S, Aoki H, Numata I, Takeda A, Namiki S, Namima T, Ikeda Y, Kambe K, Kyan A, Ueno S, Orikasa K, Katoh S, Adachi H, Tokuyama S, Ishidoya S, Yamaguchi T, Arai Y. Prospective randomized phase II trial of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma: the THP Monotherapy Study Group Trial. J Clin Oncol. 2013 Apr 10;31(11):1422-7. doi: 10.1200/JCO.2012.45.2128. Epub 2013 Mar 4.
PubMed 23460707Delto JC, Kobayashi T, Benson M, McKiernan J, Abate-Shen C. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013 Feb;4(2):269-76. doi: 10.18632/oncotarget.852.
PubMed 23563166Wu P, Zhu G, Wei D, Liu S, Walsh K, Li D, Harron U, Wang X, Ma H, Wan B, Sun L, Yang Z, Wang J. Prophylactic intravesical chemotherapy decreases bladder tumor recurrence after nephroureterectomy for primary upper tract urothelial carcinoma: A systematic review and meta-analysis. J BUON. 2015 Sep-Oct;20(5):1229-38.
PubMed 26537069Laudano MA, Barlow LJ, Murphy AM, Petrylak DP, Desai M, Benson MC, McKiernan JM. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology. 2010 Jan;75(1):134-7. doi: 10.1016/j.urology.2009.06.112. Epub 2009 Nov 13.
PubMed 19913890Lu S, Neoh KG, Kang ET, Mahendran R, Chiong E. Mucoadhesive polyacrylamide nanogel as a potential hydrophobic drug carrier for intravesical bladder cancer therapy. Eur J Pharm Sci. 2015 May 25;72:57-68. doi: 10.1016/j.ejps.2015.03.006. Epub 2015 Mar 13.
PubMed 25772330Barlow L, McKiernan J, Sawczuk I, Benson M. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guerin therapy. BJU Int. 2009 Oct;104(8):1098-102. doi: 10.1111/j.1464-410X.2009.08543.x. Epub 2009 Apr 15.
PubMed 19389012
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study
- ClinicalTrials.gov ID
- NCT03209206
- Acronym / sponsor ID
- SeoulNUHUro
- Conditions
- Urothelial Carcinoma
- Keywords
- Intravesical Chemotherapy, Docetaxel, Radical Nephroureterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 19 Jun 2020 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 6 Jul 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 investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).
Detailed description
Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.
In this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Phase II Trial
| Arm | Type | Receives |
|---|---|---|
| Docetaxel bladder instillation arm | Experimental | Drug: DocetaxelAfter Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline) |
| Control arm | Placebo comparator | Drug: Placebo Normal salineAfter Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Upper urinary tract urothelial cell carcinoma
- Hb>10g/dL, ANC >1500mm3, Platelet > 100K
- Total bilirubin : 1.5 times lower than the normal upper limit
- AST/ALT: 1.8 times lower than the normal upper limit
- Alkaline phosphatase: 1.8 times lower than the normal upper limit
Key exclusion criteria (13 listed)
- Concomitant bladder tumor
- Patients diagnosed with bladder cancer within the last 3 years
- Previous history of hypersensitivity to Docetaxel
- Neurogenic Bladder
- Patients who received chemotherapy for cancer within the last 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 |
|---|---|---|
| DocetaxelAlso: Instillation docetaxel after radical nephroureterectomyIntravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs) | Drug | Docetaxel bladder instillation arm |
| Placebo Normal salineAlso: Instillation Normal saline after radical nephroureterectomyIntravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs) | Drug | Control arm |
Primary outcome
Recurrence in bladder
Time frame: 2years
Present of bladder recurrence after intervention in follow up cystoscopy or CT scan
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 2years
Overall Survival
Time frame: 2years
Time to recurrence
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Results publication: PubMed 23460707Ito A, Shintaku I, Satoh M, Ioritani N, Aizawa M, Tochigi T, Kawamura S, Aoki H, Numata I, Takeda A, Namiki S, Namima T, Ikeda Y, Kambe K, Kyan A, Ueno S, Orikasa K, Katoh S, Adachi H, Tokuyama S, Ishidoya S, Yamaguchi T, Arai Y. Prospective randomized phase II trial of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma: the THP Monotherapy Study Group Trial. J Clin Oncol. 2013 Apr 10;31(11):1422-7. doi: 10.1200/JCO.2012.45.2128. Epub 2013 Mar 4.
- Results publication: PubMed 23563166Delto JC, Kobayashi T, Benson M, McKiernan J, Abate-Shen C. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013 Feb;4(2):269-76. doi: 10.18632/oncotarget.852.
- Results publication: PubMed 26537069Wu P, Zhu G, Wei D, Liu S, Walsh K, Li D, Harron U, Wang X, Ma H, Wan B, Sun L, Yang Z, Wang J. Prophylactic intravesical chemotherapy decreases bladder tumor recurrence after nephroureterectomy for primary upper tract urothelial carcinoma: A systematic review and meta-analysis. J BUON. 2015 Sep-Oct;20(5):1229-38.
- Results publication: PubMed 19913890Laudano MA, Barlow LJ, Murphy AM, Petrylak DP, Desai M, Benson MC, McKiernan JM. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology. 2010 Jan;75(1):134-7. doi: 10.1016/j.urology.2009.06.112. Epub 2009 Nov 13.
- Results publication: PubMed 25772330Lu S, Neoh KG, Kang ET, Mahendran R, Chiong E. Mucoadhesive polyacrylamide nanogel as a potential hydrophobic drug carrier for intravesical bladder cancer therapy. Eur J Pharm Sci. 2015 May 25;72:57-68. doi: 10.1016/j.ejps.2015.03.006. Epub 2015 Mar 13.
- Results publication: PubMed 19389012Barlow L, McKiernan J, Sawczuk I, Benson M. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guerin therapy. BJU Int. 2009 Oct;104(8):1098-102. doi: 10.1111/j.1464-410X.2009.08543.x. Epub 2009 Apr 15.
- 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.
Ja Hyeon Ku, M.D.,PH.D study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel in people with Urothelial Carcinoma, run by Seoul National University Hospital at 1 site 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 5 inclusion and 13 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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ja Hyeon Ku, M.D.,PH.D (+82-2-2072-0361, randyku@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence in bladder (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209206, which also lists 6 linked publications.
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 22 Dec 2017.