Intravesical InstillationPhase 2NCT03030157
Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma
A Phase 2 study testing pirarubicin(THP) in people with Intravesical Instillation, run by RenJi Hospital at 1 site in China.
Trial summary
Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravesical Instillation
- What is being tested?
- pirarubicin(THP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically diagnosed with upper tract urothelial carcinoma
- have no distant metastasis
- have an ECOG 0 to 2
- expected to receive radical nephroureterectomy
Who cannot join
- a prior history of bladder or synchronous bladder cancer
- administration of neoadjuvant chemotherapy
- the presence of severe complications
- deny to receive cytoscopy
- patients with advanced stage (T4)
- patients with contralateral UTUCs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
jiwei huang, M.D, 8613651682825, jiweihuang@outlook.com
jin zhang, 86-21-68383776, zhangjin@renji.com
About this study
Official title: Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma
Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.
- Conditions
- Intravesical Instillation
- Being tested
- pirarubicin(THP)
- Keywords
- urothelial cancer, bladder cancer, nephroureterectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pirarubicin(THP)Drug
| Study group | Role | What they receive |
|---|---|---|
| Long-term Intravesical Instillation of pirarubicin(THP) | Experimental | A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The first instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes. Receives: Drug: pirarubicin(THP) |
| Single Intravesical Instillation of pirarubicin | Active comparator | A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes. Receives: Drug: pirarubicin(THP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of bladder cancer in the first 12 month following nephroureterectomy
Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.
Measured: 12 month
Secondary outcomes (5)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2 day, 1 month and 12 month
questionnaire for quality of life
e.g QLQ C-30
Measured: baseline, 1 month and 12 month
progression-free survival
progression-free survival
Measured: 12 month
cancer-specific survival
cancer-specific survival
Measured: 12 month
overall survival
overall survival
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravesical InstillationStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong Hospital, Shanghai Pudong New Area Gongli Hospital
- Responsible party
- Principal investigator, Yiran Huang, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030157
- Sponsor's protocol ID
- RenJiH-PDU Trial
- Status last verified
- Oct 2019
- First submitted
- 17 Jan 2017
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03030157
- Acronym / sponsor ID
- RenJiH-PDU Trial
- Conditions
- Intravesical Instillation
- Keywords
- urothelial cancer, bladder cancer, nephroureterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pudong Hospital, Shanghai Pudong New Area Gongli Hospital
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term Intravesical Instillation of pirarubicin(THP) | Experimental | Drug: pirarubicin(THP)A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The first instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes. |
| Single Intravesical Instillation of pirarubicin | Active comparator | Drug: pirarubicin(THP)A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinically diagnosed with upper tract urothelial carcinoma
- have no distant metastasis
- have an ECOG 0 to 2
- expected to receive radical nephroureterectomy
Key exclusion criteria (6 listed)
- a prior history of bladder or synchronous bladder cancer
- administration of neoadjuvant chemotherapy
- the presence of severe complications
- deny to receive cytoscopy
- patients with advanced stage (T4)
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 |
|---|---|---|
| pirarubicin(THP) | Drug | Long-term Intravesical Instillation of pirarubicin(THP), Single Intravesical Instillation of pirarubicin |
Primary outcome
The incidence of bladder cancer in the first 12 month following nephroureterectomy
Time frame: 12 month
Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 day, 1 month and 12 month
questionnaire for quality of life
Time frame: baseline, 1 month and 12 month
progression-free survival
Time frame: 12 month
cancer-specific survival
Time frame: 12 month
overall survival
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
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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.
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 pirarubicin(THP) in people with Intravesical Instillation, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 6 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 9 Oct 2019. 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 China. 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. 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 jiwei huang (8613651682825, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of bladder cancer in the first 12 month following nephroureterectomy (time frame: 12 month). 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 9 Oct 2019.