Bladder Cancer
Conditions
Keywords
bladder cancer, neoadjuvant chemotherapy, gem/cis
Brief summary
To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.
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).
Interventions
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
Sponsors
Barmherzige Brüder Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic response rate | at time of surgery | evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety, number of participants with adverse events and grade of adverse events | adverse events will be evaluated after every 6 months | to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer |
Other
| Measure | Time frame | Description |
|---|---|---|
| progression free survival (PFS) | 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 |
Countries
Austria
Outcome results
None listed