Muscle-invasive bladder cancer
Conditions
Interventions
Based on the results of the prediction score and patient'
s wishes the patients were allocated into four treatments
neoadjuvant M-VAC, neoadjuvant CaG, operation or radiation therapy without neoadjuvant chemotherapy
Sponsors
Department of Urology, Iwate Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Samples had been confirmed histologically as urothelial carcinoma of the bladder are selected for this study. No node metastasis through computed tomography from their chest to pelvis and magnetic resonance imaging of their abdomen and pelvis at clinical stages T2aN0M0 to T4aN0M0 (Stage II-III) and were expected to undergo radical cystectomy without prior radiation therapy. No serious abnormality in renal, hepatic or hematologic function and an Eastern Cooperative Oncology Group performance status (PS) judged to be <=2.
Exclusion criteria
Exclusion criteria: 1) The case with serious complications 2) The case with active double cancer 3) The case with pregnancy, lactation or possibility of pregnancy 4) The case with drug allergy for G-CSF 5) The case with drug allergy for M-VAC or CaG 6) The case without the selection criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study are accuracy and efficacy of prediction systems, proportion of achieving significant tumor shrinking (>60%) by either or both of the two regimens with intention-to-treat compared with that of historical controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the overall survival between the patients of this prospective study and the historical controls. | — |
Countries
Japan
Contacts
Public ContactYoichiro Kato
Iwate Medical University Urology
Outcome results
None listed