Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01801644
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Johannes Meran, Barmherzige Brüder Vienna

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: gemcitabine plus cisplatin Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer
Study Start Date : April 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: gemzar (gemcitabine) plus cisplatin (= cisplatin)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801644


Locations
Layout table for location information
Austria
Barmherzige Brüder Vienna
Vienna, Austria, 1020
Sponsors and Collaborators
Barmherzige Brüder Vienna
Investigators
Layout table for investigator information
Principal Investigator: Johannes Meran, M.D. Barmherzige Brüder Vienna

Publications of Results:
Tolerability of neoadjuvant chemotherapy with gemcitabine plus cisplatin in elderly (older than age 65) patients (pts) with muscle-invasive urothelial cancer. D. Niedersuess-Beke, B. Gruenberger, T. Puntus, W. Bauer, M. Lamche, P. Schramek, J. G. Meran; Barmherzige Brueder Hospital, Vienna, Austria; Goettlicher Heiland Hospital, Vienna, Austria ´ J Clin Oncol 29: 2011 (suppl 7; abstr 296)

Other Publications:
Layout table for additonal information
Responsible Party: Johannes Meran, Prof. Dr.Johannes Meran, Barmherzige Brüder Vienna
ClinicalTrials.gov Identifier: NCT01801644     History of Changes
Other Study ID Numbers: Bladder Cancer-001
Bladder Cancer-001 ( Other Identifier: Barmherzige Brüder, Austria )
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013

Keywords provided by Johannes Meran, Barmherzige Brüder Vienna:
bladder cancer
neoadjuvant chemotherapy
gem/cis

Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Cisplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs