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NCT02547350 Clinical Trial

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

Upper Tract Urothelial Carcinoma Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02547350
Other study ID # PIC-UTUC
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received September 8, 2015
Last updated September 9, 2015
Start date September 2015

Study information
Verified date September 2015
Source Peking University First Hospital
Contact n/a
Is FDA regulated No
Health authority China: Beijing Municipal Health Bureau
Study type Interventional

Clinical 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• pharmorubicin or pirarubicin
pharmorubicin 50mg pirarubicin 30mg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Xuesong Li

Outcome
Type Measure Description Time frame Safety issue
Primary intravesical recurrence-free survival two years after surgery No
Secondary cancer-specific survival two years after surgery No
See also
  Status Clinical Trial Phase
Recruiting NCT04948528 - Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
Recruiting NCT05917158 - A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma Phase 2
Recruiting NCT02923557 - Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma Patients Phase 2
Recruiting NCT02969083 - Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma Phase 2
Recruiting NCT03544437 - Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma
Recruiting NCT03230201 - Lymph Node Dissection in High-risk UTUC(Upper Tract Urothelial Carcinoma) N/A
Recruiting NCT02740426 - Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Diagnostic Ureteroscopy for Primary Upper Tract Urothelial Carcinoma Patients Phase 2
Active, not recruiting NCT03617003 - Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) Phase 1