Chemoradiation with once weekly gemcitabine for invasive bladder cancer

• Conditions: Invasive transitional cell bladder cancer

• Registration Number: EUCTR2004-003906-81-LT
• Lead Sponsor: Oncology Institute of Vilnius University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with clinical stage T2 - T4, N0 - N1, M0 transitional cell bladder cancer without hydronephrosis after transurethral resection, ECOG<= 2, age>18 y and <80 y, kreatinine clearance >65 ml/min, without cystostomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with non invasive ormetastatic transitional cell bladder cancer, ECOG>2, age>80 and <18 y, cystostomy, mental disorders, graviditas.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety, tolerance and efficacy of concomitant gemcitabine with radiation in conjunction with selective bladder preservation in patients with muscle - invading bladder cancer.;Secondary Objective: 1. To investigate predictive value of molecular markers (bcl-2, ki-67, p21, PCNA) evaluating response to chemoradiation, relationship with tumor stage, grade and metastases of lymphonodes.<br>2. To investigate concomitant chemoradiation with gemcitabine in vivo and in vitro.;Primary end point(s): To evaluate efficacy complete response), toxicity and bladder preservation of concomitant chemoradiation with gemcitabine for the treatment of invasive transitional cell bladder cancer; to establish predictive value of molecular markers (bcl-2, ki-67, p21,PCNA) to predict response tochemoradiation; to evaluate radiosensibilisying effects of gemcitabine in vivo and in vitro.