Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

Xuesong Li

Status and phase: Unknown; Phase 2

Conditions: Bladder Recurrence; Upper Tract Urothelial Carcinoma

Treatments: Drug: pharmorubicin or pirarubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02547350

PIC-UTUC

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who were clinically diagnosed with UTUC
2. Treated with radical nephroureterectomy

Exclusion criteria

1. Distant metastasis
2. Prior history of bladder or synchronous bladder cancer
3. Administration of neoadjuvant chemotherapy
4. Presence of severe complications.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Blank control

No Intervention group

Description:

do not use prophylactic intravesical chemotherapy

single intravesical instillation

Experimental group

Description:

intravesical instillation within 24 hours postoperatively

Treatment:

Drug: pharmorubicin or pirarubicin

multiple intravesical instillation

Experimental group

Description:

intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months

Treatment:

Drug: pharmorubicin or pirarubicin