Upper Tract Urothelial CarcinomaPhase 2NCT02547350
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
A Phase 2 study testing pharmorubicin or pirarubicin in people with Upper Tract Urothelial Carcinoma and Bladder Recurrence, run by Xuesong Li.
Trial summary
The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Tract Urothelial Carcinoma, Bladder Recurrence
- What is being tested?
- pharmorubicin or pirarubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were clinically diagnosed with UTUC
- Treated with radical nephroureterectomy
Who cannot join
- Distant metastasis
- Prior history of bladder or synchronous bladder cancer
- Administration of neoadjuvant chemotherapy
- Presence of severe complications.
About this study
The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).
- Being tested
- pharmorubicin or pirarubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmorubicin or pirarubicinDrug
pharmorubicin 50mg pirarubicin 30mg
| Study group | Role | What they receive |
|---|---|---|
| Blank control | No intervention | do not use prophylactic intravesical chemotherapy |
| single intravesical instillation | Experimental | intravesical instillation within 24 hours postoperatively Receives: Drug: pharmorubicin or pirarubicin |
| multiple intravesical instillation | Experimental | intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months Receives: Drug: pharmorubicin or pirarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravesical recurrence-free survival
Measured: two years after surgery
Secondary outcomes (1)
cancer-specific survival
Measured: two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuesong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547350
- Sponsor's protocol ID
- PIC-UTUC
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
- ClinicalTrials.gov ID
- NCT02547350
- Acronym / sponsor ID
- PIC-UTUC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuesong LiUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2020 (estimated)
- First posted
- 11 Sep 2015 (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.
The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blank control | No intervention | –do not use prophylactic intravesical chemotherapy |
| single intravesical instillation | Experimental | Drug: pharmorubicin or pirarubicinintravesical instillation within 24 hours postoperatively |
| multiple intravesical instillation | Experimental | Drug: pharmorubicin or pirarubicinintravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were clinically diagnosed with UTUC
- Treated with radical nephroureterectomy
Key exclusion criteria (4 listed)
- Distant metastasis
- Prior history of bladder or synchronous bladder cancer
- Administration of neoadjuvant chemotherapy
- Presence of severe complications.
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 |
|---|---|---|
| pharmorubicin or pirarubicinpharmorubicin 50mg pirarubicin 30mg | Drug | multiple intravesical instillation, single intravesical instillation |
Primary outcome
intravesical recurrence-free survival
Time frame: two years after surgery
1 secondary outcome
cancer-specific survival
Time frame: two years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pharmorubicin or pirarubicin in people with Upper Tract Urothelial Carcinoma and Bladder Recurrence, run by Xuesong Li.
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 2 inclusion and 4 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 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravesical recurrence-free survival (time frame: two years after surgery). 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 11 Sep 2015.