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

March 22, 2016 updated by: The First Affiliated Hospital with Nanjing Medical University

Prospective Cohort Study of Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Moderate-high Recurrence and Progression Risks of Muscle-invasive Bladder Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Monotherapy
Barely epirubicin was instilled after TURBT. Epirubicin was immediately instilled in 24h after TURBT. Instillation was conducted regularly for a year: once in a week for 8 times, once in two weeks for 8 times, once in a month for 6 times.
EXPERIMENTAL: Combination
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.
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.
Other Names:
  • Combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor progression
Time Frame: Changes from post-chemotherapy to 5 years
Changes from post-chemotherapy to 5 years
Drug intervention complications
Time Frame: 2 years
WBC and PLT decreasing, impaired liver function, nausea and vomiting
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The percent of patients transferred to radical cystectomy.
Time Frame: Up to 5 years
Up to 5 years
The existence of circulating tumor cells.
Time Frame: Before and 4 months after TURBT.
Before and 4 months after TURBT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Qiang Lu, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (ESTIMATE)

March 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-SR-193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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