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

Intravesical Instillation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03030157
• Other study ID #: RenJiH-PDU Trial
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: October 2019
• Source: RenJi Hospital
• Contact: jiwei huang
• Phone: 8613651682825
• Email: jiweihuang[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Intravesical Instillation
• Recurrence

Intervention

Drug:
• pirarubicin(THP)

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Pudong Hospital, Shanghai Pudong New Area Gongli Hospital

Country where clinical trial is conducted

China, 

Outcome

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