Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk
- 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
- 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.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 .
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Eli Lilly and Company
Italy: Ministry of Health
- Superficial Bladder Cancer
- Urinary Bladder Neoplasms