Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03030157

Enrollment

220

Registered

2017-01-24

Start date

2017-01-31

Completion date

2020-01-31

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravesical Instillation

Keywords

urothelial cancer, bladder cancer, nephroureterectomy

Brief 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. 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.

Interventions

DRUGpirarubicin(THP)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* clinically diagnosed with upper tract urothelial carcinoma * have no distant metastasis * have an ECOG 0 to 2 * expected to receive radical nephroureterectomy

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of bladder cancer in the first 12 month following nephroureterectomy	12 month	Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.

Secondary

Measure	Time frame	Description
questionnaire for quality of life	baseline, 1 month and 12 month	e.g QLQ C-30
progression-free survival	12 month	progression-free survival
cancer-specific survival	12 month	cancer-specific survival
overall survival	12 month	overall survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	2 day, 1 month and 12 month	—

Countries

China

Contacts

Primary Contactjiwei huang

jiweihuang@outlook.com8613651682825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026