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Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer

NCT02716961 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2016-03-24

No results posted yet for this study

Summary

It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC.

Conditions

  • Bladder Cancer
  • Gemcitabine and Cisplatin Chemotherapy
  • Epirubicin Instillation
  • Recurrence
  • Prognosis

Interventions

DRUG

Gemcitabine, cisplatin

Patients who were pathologically confirmed as moderate-high risk NMIBC. Epirubicin was immediately instilled in 24h after TURBT and regularly conducted for a year. GC scheme systematic chemotherapy was underwent 5 days after TURBT, which contained gemcitabine 1000-1200mg/m2. Cisplatin (70mg/m2) was intravenous dripped in the first and 8th day after TURBT. Intravenous rehydration was conducted in the second day.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Qiang Lu, PhD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716961 on ClinicalTrials.gov