Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT00028756
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed transitional cell carcinoma of the bladder urothelium
* T3-4, N1-3, M0
* No pure squamous cell or adenocarcinoma tumors
* No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy without evidence of microscopic residual disease
* Performance status - WHO 0-1
* WBC at least 3,500/mm\^3
* Platelet count at least 120,000/mm\^3
* SGOT/SGPT less than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2.5 times ULN
* Bilirubin normal
* Glomerular filtration rate greater than 60 mL/min
* No clinically significant cardiac arrhythmia
* No congestive heart failure
* No complete bundle branch block
* No New York Heart Association class III or IV heart disease
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after study
* Considered fit for cisplatin-containing combination chemotherapy
* No clinically abnormal auditory function
* No known hypersensitivity to E. coli-derived drug preparations
* No grade 2 or greater peripheral neuropathy
* No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer (pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)
* No psychological, familial, sociological, or geographical condition that would preclude study involvement
* No prior systemic chemotherapy
* No prior radiotherapy to the bladder
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00028756
Study Brief:
Protocol Section:
NCT00028756