Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

February 28, 2013 updated by: Johannes Meran, Barmherzige Brüder Vienna

Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy.

Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.

Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).

Study Type

Interventional

Enrollment (Actual)

60

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

  • Austria
      • Vienna, Austria, 1020
        • Barmherzige Brüder Vienna

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age
  • histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • bone marrow reserve (neutrophil count >1500 cells per μL,platelet count >100 000 per μL) count
  • hepatic function (serum bilirubin <2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
  • renal function with a creatinine clearance >60ml/min

Exclusion Criteria:

  • metastatic disease
  • serious or uncontrolled concurrent medical illness
  • pregnancy
  • history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
  • non-transitional cell bladder cancer
  • creatinine clearance <60ml/min

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gemcitabine plus cisplatin
gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied
Drug: gemcitabine plus cisplatin
gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion
Other Names:
  • gemzar (gemcitabine) plus cisplatin (= cisplatin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologic response rate
Time Frame: at time of surgery
evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy
at time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety, number of participants with adverse events and grade of adverse events
Time Frame: adverse events will be evaluated after every 6 months
to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer
adverse events will be evaluated after every 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: up to 5 years after including the last patient
pfs will be assessed avery 3 months in the first year after radical cystectomy, every 6 months in the second year, and yearly from the 3rd year up to a minimum follow up of 5 years
up to 5 years after including the last patient

Collaborators and Investigators

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

Sponsor

Barmherzige Brüder Vienna

Investigators

  • Principal Investigator: Johannes Meran, M.D., Barmherzige Brüder Vienna

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

April 1, 2007

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bladder Cancer-001 (Other Identifier: Barmherzige Brüder, Austria)

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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