urothelial cancer
Conditions
Interventions
None listed
Sponsors
Hirosaki University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have histologic proof of urothelial cancer. Patients with primary tumors arising in the upper urinary tract (ureter or renal pelvis), bladder or urethra are eligible Patients must have an evaluation in the department of urology. ECOG performance status (PS) of 0, 1 or 2 if of recent onset and due entirely to the cancer and not due to comorbidity (especially if the compromised performance status is related to uncontrolled pain which is expected to be rapidly reversible when therapy starts) Normal liver function (Transaminase (AST or ALT) </= 3 * the ULN, Conjugated bilirubin </= 1.5 mg/dl (or total bilirubin </= 2.5 mg/dl) No severe chronic heart failure Not severe renal dysfunction (eGFR < 30 ml/min/1.72m2) Patients with other malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen. The expected survival from the prior malignancy should reliably be > 4 years to be eligible for this study. Patients must be >/= 20 years of age.
Exclusion criteria
Exclusion criteria: Patients must not have current, recent (within 3 weeks), or planned participation with other experimental medication clinical trials. New York Heart Association (NYHA) Grade II or greater congestive heart failure. History of myocardial infarction or unstable angina within 6 months prior to study enrollment. History of stroke or transient ischemic attack within 6 months prior to study enrollment. Clinically significant peripheral vascular disease (e.g., aortic aneurysm, aortic dissection). Symptomatic peripheral vascular disease. Evidence of bleeding diathesis or coagulopathy. Known history of central nervous system or brain metastases. Lactating women. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to therapy. Patients with Crohn's disease will be excluded. Serious, non-healing wound, ulcer, or bone fracture. Other malignancies with severe prognosis (overall survival expected within 1 year) Inability to comply with study and/or follow-up procedures, or sign informed consent. Patients who are not candidates, or are unwilling to undergo systemic chemotherapy. Patients with fluid collections (such as ascites, or pleural effusions) are not eligible for therapy. Know hypersensitivity to any component of gemcitabine, cisplatin, or carboplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety. | — |
Countries
Japan
Contacts
Public ContactItsuto Hamano
Hirosaki University Graduate School of Medicine Urology
Outcome results
None listed