Invasive transitional cell bladder cancer
Conditions
Interventions
Trade Name: Gemzar
Product Name: Gemcitabini hydrochloridi
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Oncology Institute of Vilnius University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinical stage T2 - T4, N0 - N1, M0 transitional cell bladder cancer without hydronephrosis after transurethral resection, ECOG18 y and 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
Exclusion criteria: Patients with non invasive ormetastatic transitional cell bladder cancer, ECOG>2, age>80 and <18 y, cystostomy, mental disorders, graviditas.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Lithuania
Outcome results
None listed