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

Not Applicable

• Conditions: Bladder Cancer; Gemcitabine and Cisplatin Chemotherapy; Epirubicin Instillation; Recurrence; Prognosis
• Interventions: Drug: Gemcitabine, cisplatin

• Registration Number: NCT02716961
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Prevention of the post-transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder cancer(NMIBC) is still a difficult problem. NMIBC was classified as low, moderate and high risk patients. Moderate-high risk NMIBC contained those are multiple, recurrent, II-III grade, tumor diameter \>3cm, invasive to submucosa and associated with carcinoma in situ. For those patients, no matter which treatment was conducted, for example, exchanging instillation drugs, increasing medicine dose, appending adjuvant drugs and prolonging instillation time, would not improve the prognosis of these patients. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. For muscle invasive bladder cancer patients, radical cystectomy with neoadjuvant chemotherapy will improve patients' tumor grade and increase overall survival and disease specific survival rate.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. In addition, we also would like to investigate the improvement of life quality after TURBT of moderate-high risk NMIBC.

Study Timeline

• Status Verified: 2015-11
• Study Start: 2016-01
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-22
• Study First Posted: 2016-03-23
• Last Update Posted: 2016-03-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1. moderate-high risk non-muscle invasive bladder cancer patients: Multiple,recurrent, II-III grade, tumor diameter>3cm, invasive to submucosa, associated with carcinoma in situ.
2. Normal liver and renal function.

Exclusion Criteria

1. Liver and renal function deficiency (GFR<60ml/min*kg, ALT、AST>1.5*normal), lung function deficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension and anaerobic conditions.
2. Attending other drug experiments.
3. Performance status, Zubrod-ECOG-WHO, ZPS≥2.
4. Pregnant.
5. Bone marrow transplantation, severe leukopenia, associated with severe infection or injury.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination	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. Intervention: 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.

Primary Outcome Measures

Name	Time	Method
Tumor progression	Changes from post-chemotherapy to 5 years
Drug intervention complications	2 years	WBC and PLT decreasing, impaired liver function, nausea and vomiting

Secondary Outcome Measures

Name	Time	Method
The existence of circulating tumor cells.	Before and 4 months after TURBT.
The percent of patients transferred to radical cystectomy.	Up to 5 years

Trial Locations

Locations (1)

The first affiliated hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China