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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00014534
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma of the bladder
* Any T, N+, M0 OR
* T3a-4a, N0, M0
* At least 6 weeks but no more than 3 months since prior complete resection of bladder
* Cystoprostatectomy plus pelvic lymph node dissection in males
* Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus pelvic lymph node dissection in females
* Negative surgical margins
* Carcinoma in situ allowed
* No partial cystectomy or transurethral bladder tumor resection as definitive loco-regional therapy
* Prostate cancer detected in resected specimen allowed if post-operative PSA is no more than 0.05 mg/dL
* No metastatic or recurrent disease by post-operative chest x-ray and CT scan of abdomen and pelvis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Hematopoietic:
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 150,000/mm\^3
Hepatic:
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* AST ≤ 2 times ULN
Renal:
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular:
* Normal cardiac function by history, physical exam, or chest radiograph
* Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram, for prior cardiac disease
* No New York Heart Association class III or IV heart disease
* No serious cardiac arrhythmias including first-, second-, and third-degree heart block
Other:
* Negative pregnancy test
* No uncontrolled infection
* No other active cancer within the past 5 years except non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior systemic chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to bladder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00014534
Study Brief:
Protocol Section:
NCT00014534