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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Intravesical Instillation

Treatments: Drug: pirarubicin(THP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03030157

RenJiH-PDU Trial

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Long-term Intravesical Instillation of pirarubicin(THP)

Experimental group

Description:

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.

Treatment:

Drug: pirarubicin(THP)

Single Intravesical Instillation of pirarubicin

Active Comparator group

Description:

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.

Treatment:

Drug: pirarubicin(THP)