Superficial Bladder Cancer
Conditions
Brief summary
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.
Interventions
DRUGGemcitabine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk * Urinary cytology negative for severe dysplasia (G3). * ECOG performance status 0-1 * Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy * Absence of other present or past neoplasias except for healed skin basalioma
Exclusion criteria
* Tumours with infiltrative patterns at cystoscopy * Transitional carcinoma of the upper urinary tract and prostatic urethra. * Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer . | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess toxicity profile in the same group of patients. | — |
Countries
Italy
Outcome results
None listed