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 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT00080795
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease:
* Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia
* Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum
* Lymphovascular invasion on transurethral resection specimen
* Upper tract disease or micropapillary histology allowed
* No evidence of disease outside the pelvis
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* 0-2
Life expectancy
* Not specified
Hematopoietic
* Bone marrow function adequate
Hepatic
* Liver function adequate
Renal
* Creatinine clearance ≥ 45 mL/min
Cardiovascular
* Ejection fraction ≥ 50%
Other
* Not pregnant
* No other malignancy likely to be life-threatening within the next 4 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00080795
Study Brief:
Protocol Section:
NCT00080795